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ACTIVE PHARMA INGREDIENTS

28 API Suppliers, 15 USDMF, 10 CEP/COS, 2 JDMF, 5 EU WC, 5 KDMF, 20 NDC API, 15 Listed Suppliers, $ API Reference Price

28 API Suppliers
15 USDMF
10 CEP/COS
2 JDMF
5 EU WC
5 KDMF
20 NDC API
15 Listed Suppliers
$ API Reference Price

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9 Drugs in Development

9 Drugs in Development

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5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

595 FDF Dossiers, 263 FDA Orange Book, 187 Europe, 29 Canada, 37 Australia, 24 South Africa, 55 Listed Dossiers

595 FDF Dossiers
263 FDA Orange Book
187 Europe
29 Canada
37 Australia
24 South Africa
55 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.0125MG;0.0031MG, TABLET;ORAL - 0.025MG;0.0063MG, TABLET;ORAL - 0.05MG;0.0125MG, TABLET;ORAL - 0.15MG;0.0375MG, TABLET;ORAL - 0.1MG;0.025MG, POWDER;INTRAVENOUS - 100MCG/VIAL, POWDER;INTRAVENOUS - 200MCG/VIAL, POWDER;INTRAVENOUS - 500MCG/VIAL, TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, CAPSULE;ORAL - 0.013MG, CAPSULE;ORAL - 0.025MG, CAPSULE;ORAL - 0.0375MG, CAPSULE;ORAL - 0.044MG, CAPSULE;ORAL - 0.05MG, CAPSULE;ORAL - 0.0625MG, CAPSULE;ORAL - 0.075MG, CAPSULE;ORAL - 0.088MG, CAPSULE;ORAL - 0.112MG, CAPSULE;ORAL - 0.125MG, CAPSULE;ORAL - 0.137MG, CAPSULE;ORAL - 0.15MG, CAPSULE;ORAL - 0.175MG, CAPSULE;ORAL - 0.1MG, CAPSULE;ORAL - 0.2MG

drugProductComposition
TABLET;ORAL - 0.0125MG;0.0031MG
TABLET;ORAL - 0.025MG;0.0063MG
TABLET;ORAL - 0.05MG;0.0125MG
TABLET;ORAL - 0.15MG;0.0375MG
TABLET;ORAL - 0.1MG;0.025MG
POWDER;INTRAVENOUS - 100MCG/VIAL
POWDER;INTRAVENOUS - 200MCG/VIAL
POWDER;INTRAVENOUS - 500MCG/VIAL
TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
CAPSULE;ORAL - 0.013MG
CAPSULE;ORAL - 0.025MG
CAPSULE;ORAL - 0.0375MG
CAPSULE;ORAL - 0.044MG
CAPSULE;ORAL - 0.05MG
CAPSULE;ORAL - 0.0625MG
CAPSULE;ORAL - 0.075MG
CAPSULE;ORAL - 0.088MG
CAPSULE;ORAL - 0.112MG
CAPSULE;ORAL - 0.125MG
CAPSULE;ORAL - 0.137MG
CAPSULE;ORAL - 0.15MG
CAPSULE;ORAL - 0.175MG
CAPSULE;ORAL - 0.1MG
CAPSULE;ORAL - 0.2MG

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GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions, 177 Finished Drug Prices, 8 Annual Reports

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8 US Medicaid Prescriptions
177 Finished Drug Prices
8 Annual Reports

MARKET PLACE

30 APIs, 14 FDF Dossiers

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30 APIs
14 FDF Dossiers

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125 US Patents

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125 US Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 3 USP , 3 Others

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3 EDQM
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3 Others

ANALYTICAL

1 BioAnalytical Methods

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1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 6,623

MARKET PLACE

API

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5INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

595

FDF Dossiers

263

FDA Orange Book

187

Europe

Canada

Australia

South Africa

Listed Dossiers

9DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

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USP

Others

PATENTS & EXCLUSIVITIES

125

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Health Canada Patents

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GLOBAL SALES INFORMATION

US Medicaid (USD)

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Annual Reports (USD Million)

5,367

Finished Drug Prices

274 RELATED EXCIPIENT COMPANIES

451EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 25416-65-3, Levothyroxine sodium, L-thyroxine sodium xhydrate, Levothyroxine sodium hydrate, L-thyroxine sodium hydrate, Monosodium l-thyroxine hydrate

Molecular Formula

C₁₅H₁₂I₄NNaO₅

Molecular Weight

816.87 g/mol

InChI Key

ANMYAHDLKVNJJO-LTCKWSDVSA-M

FDA UNII

B82379R9W0

The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism.

1 2D Structure

Levothyroxine Sodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate;hydrate

2.1.2 InChI

InChI=1S/C15H11I4NO4.Na.H2O/c16-8-4-7(5-9(17)13(8)21)24-14-10(18)1-6(2-11(14)19)3-12(20)15(22)23;;/h1-2,4-5,12,21H,3,20H2,(H,22,23);;1H2/q;+1;/p-1/t12-;;/m0../s1

2.1.3 InChI Key

ANMYAHDLKVNJJO-LTCKWSDVSA-M

2.1.4 Canonical SMILES

C1=C(C=C(C(=C1I)OC2=CC(=C(C(=C2)I)O)I)I)CC(C(=O)[O-])N.O.[Na+]

2.1.5 Isomeric SMILES

C1=C(C=C(C(=C1I)OC2=CC(=C(C(=C2)I)O)I)I)C[C@@H](C(=O)[O-])N.O.[Na+]

2.2 Other Identifiers

2.2.1 UNII

B82379R9W0

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 3,5,3',5'-tetraiodothyronine

2. Berlthyrox

3. Dexnon

4. Eferox

5. Eltroxin

6. Eltroxine

7. Euthyrox

8. Eutirox

9. L Thyrox

10. L Thyroxin Beta

11. L Thyroxin Henning

12. L Thyroxine

13. L Thyroxine Roche

14. L-3,5,3',5'-tetraiodothyronine

15. L-thyrox

16. L-thyroxin Beta

17. L-thyroxin Henning

18. L-thyroxine

19. L-thyroxine Roche

20. Lvothyrox

21. Levo T

22. Levo-t

23. Levothroid

24. Levothyroid

25. Levothyroxin Deladande

26. Levothyroxin Delalande

27. Levothyroxine

28. Levothyroxine Sodium

29. Levoxine

30. Levoxyl

31. Novothyral

32. Novothyrox

33. O-(4-hydroxy-3,5-diiodophenyl) 3,5-diiodo-l-tyrosine

34. O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodotyrosine

35. Oroxine

36. Sodium Levothyroxine

37. Synthroid

38. Synthrox

39. T4 Thyroid Hormone

40. Thevier

41. Thyrax

42. Thyroid Hormone, T4

43. Thyroxin

44. Thyroxine

45. Tiroidine

46. Tiroxina Leo

47. Unithroid

2.3.2 Depositor-Supplied Synonyms

1. 25416-65-3

2. Levothyroxine Sodium

3. L-thyroxine Sodium Xhydrate

4. Levothyroxine Sodium Hydrate

5. L-thyroxine Sodium Hydrate

6. Monosodium L-thyroxine Hydrate

7. 31178-59-3

8. Chebi:6447

9. Levothroid

10. Synthroid

11. Levothyrox

12. Levaxin

13. Levoxyl

14. Oroxine

15. Soloxine

16. Eferox

17. Sodium;(2s)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate;hydrate

18. B82379r9w0

19. Thyroxine Sodium

20. Levo-t

21. Liotrix (t4)

22. Thyroxine Sodium Salt

23. L-tyrosine, O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-, Monosodium Salt, Monohydrate

24. Latequatro

25. Letequatro

26. Levoroxin

27. Levotiron

28. Tiroxina

29. Tivoral

30. Levo-tiroxina Glaxo

31. Nsc-259940

32. L-tyrosine, O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-, Monosodium Salt, Hydrate

33. Unii-b82379r9w0

34. Levothroid (tn)

35. Synthroid (tn)

36. Levoxyl (tn)

37. Levothyroxine Sodium [usp:inn:jan]

38. Starbld0009614

39. L-thyroxin Monosodium Salt

40. T4 (liotrix)

41. Levothyroxine Sodium (usp)

42. Schembl2327406

43. Chembl2103741

44. L-thyroxine Sodium Salt Monohydrate

45. 3,3',5,5'-tetraiodo-l-thyronine Monosodium Salt Hydrate

46. Levothyroxine Sodium Hydrate (jp17)

47. Mfcd06408007

48. Akos015895962

49. Ks-1237

50. D01010

51. E78443

52. Levothyroxine Sodium Monohydrate [who-ip]

53. 3,3',5,5'-tetraiodo-l-thyronine Monosodium Salt

54. A817851

55. Q27107209

56. Levothyroxinum Natricum Monohydrate [who-ip Latin]

57. Sodium 2-amino-3-[4-(4-hydroxy-3,5-diiodo-phenoxy)-3,5-diiodo-phenyl]propanoate Hydrate

58. Sodium (s)-2-amino-3-(4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl)propanoate Xhydrate

2.4 Create Date

2008-02-05

3 Chemical and Physical Properties

Molecular Formula	C₁₅H₁₂I₄NNaO₅
Molecular Weight	816.87 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	5
Exact Mass	816.6792 g/mol
Monoisotopic Mass	816.6792 g/mol
Topological Polar Surface Area	96.6 Å²
Heavy Atom Count	26
Formal Charge	0
Complexity	426
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

4 Drug and Medication Information

4.1 Drug Information

1 of 8
Drug Name	Levo-t
Drug Label	Levothyroxine sodium tablets, USP contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland.Levothyroxine (T4) sodium has an empir
Active Ingredient	Levothyroxine sodium
Dosage Form	Tablet
Route	Oral
Strength	0.05mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
Market Status	Prescription
Company	Alara Pharm

2 of 8
Drug Name	Levothroid
PubMed Health	Thyroid Supplement (By mouth)
Drug Classes	Diagnostic Agent, Thyroid Function, Thyroid Supplement
Drug Label	LEVOTHROID (levothyroxine sodium tablets, USP) contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodiu
Active Ingredient	Levothyroxine sodium
Dosage Form	Tablet
Route	Oral
Strength	0.05mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
Market Status	Prescription
Company	Lloyd

3 of 8
Drug Name	Levothyroxine sodium
Active Ingredient	Levothyroxine sodium
Dosage Form	Tablet; Powder; Injectable
Route	injection; Oral; Intravenous
Strength	0.05mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 200mcg/vial; 0.112mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 descr
Market Status	Prescription
Company	Fresenius Kabi Usa; Mylan

4 of 8
Drug Name	Levoxyl
Drug Label	LEVOXYL (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3,5,5-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodiu...
Active Ingredient	Levothyroxine sodium
Dosage Form	Tablet
Route	Oral
Strength	0.05mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
Market Status	Prescription
Company	King Pharms R And D

5 of 8
Drug Name	Levo-t
Drug Label	Levothyroxine sodium tablets, USP contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland.Levothyroxine (T4) sodium has an empir
Active Ingredient	Levothyroxine sodium
Dosage Form	Tablet
Route	Oral
Strength	0.05mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
Market Status	Prescription
Company	Alara Pharm

6 of 8
Drug Name	Levothroid
PubMed Health	Thyroid Supplement (By mouth)
Drug Classes	Diagnostic Agent, Thyroid Function, Thyroid Supplement
Drug Label	LEVOTHROID (levothyroxine sodium tablets, USP) contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodiu
Active Ingredient	Levothyroxine sodium
Dosage Form	Tablet
Route	Oral
Strength	0.05mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
Market Status	Prescription
Company	Lloyd

7 of 8
Drug Name	Levothyroxine sodium
Active Ingredient	Levothyroxine sodium
Dosage Form	Tablet; Powder; Injectable
Route	injection; Oral; Intravenous
Strength	0.05mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 200mcg/vial; 0.112mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 descr
Market Status	Prescription
Company	Fresenius Kabi Usa; Mylan

8 of 8
Drug Name	Levoxyl
Drug Label	LEVOXYL (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3,5,5-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodiu...
Active Ingredient	Levothyroxine sodium
Dosage Form	Tablet
Route	Oral
Strength	0.05mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
Market Status	Prescription
Company	King Pharms R And D

5 Pharmacology and Biochemistry

5.1 FDA Pharmacological Classification

5.1.1 Pharmacological Classes

l-Thyroxine [EPC]; Thyroxine [CS]

5.2 ATC Code

H - Systemic hormonal preparations, excl. sex hormones and insulins

H03 - Thyroid therapy

H03A - Thyroid preparations

H03AA - Thyroid hormones

H03AA01 - Levothyroxine sodium

API SUPPLIERS

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USDMF

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CEP/COS

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JDMF

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EU WC

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KDMF

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NDC API

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Listed Suppliers

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API Reference Price

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(LEVOTHYROXINE SODIUM MILLED 119320)","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"MUNICH","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"4.72","actualQuantity":"4718","unit":"GMS","unitRateFc":"7.2","totalValueFC":"36876.4","currency":"USD","unitRateINR":"652.5","date":"13-Jun-2024","totalValueINR":"3078420.18","totalValueInUsd":"36876.4","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"3981371","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"MUNICH","supplierAddress":"61 SOUTH PARAMUS ROAD,SUITE 565 PARAMUS,NEW JERSEY 07652 UNITED STATES","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719167400,"product":"LEVOTHYROXINE SODIUM PH EUR","address":"WOCKHARDT TOWERS, BANDRA KURLA","city":"MUMBAI, MAHARASHTRA.","supplier":"WELDING GMBH& CO KG","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"WOCKHARDT","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"11800","totalValueFC":"25782.6","currency":"EUR","unitRateINR":"1076160","date":"24-Jun-2024","totalValueINR":"2152320","totalValueInUsd":"25782.6","indian_port":"Bombay Air","hs_no":"29379090","bill_no":"4159686","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ESPLANADE 39 - 20354 HAMBURGSDNFSDNF Germany","customerAddress":"WOCKHARDT TOWERS, BANDRA KURLA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719599400,"product":"LEVOTHYROXINE SODIUM","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"WELDING GMBH & CO.KG","supplierCountry":"GERMANY","foreign_port":"FRANKFURT AM MAIN","customer":"VIATRIS","customerCountry":"INDIA","quantity":"80.00","actualQuantity":"80000","unit":"GMS","unitRateFc":"5.7","totalValueFC":"462010.7","currency":"USD","unitRateINR":"482.1","date":"29-Jun-2024","totalValueINR":"38568390","totalValueInUsd":"462010.7","indian_port":"Indore-EPZ\/SEZ","hs_no":"29379090","bill_no":"1004758","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT AM MAIN","supplierAddress":"ESPLANADE 39,D - 20354,HAMBURG,","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723401000,"product":"LEVOTHYROXINE SODIUM (FOC)","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"MAIA PHARMACEUTICALS LLC","supplierCountry":"SWITZERLAND","foreign_port":"NEWARK, NJ","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"4.6","totalValueFC":"562","currency":"USD","unitRateINR":"471.4","date":"12-Aug-2024","totalValueINR":"47137.01","totalValueInUsd":"562","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"5007990","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NEWARK, NJ","supplierAddress":"707 STATE RD STE 104PRINCETON, NJ 08540USA US","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727634600,"product":"LEVOTHYROXINE SODIUM","address":"PLOT NO 75 INDUSTRIAL AREA PHASE -","city":"CHANDIGARH,CHANDIGARH","supplier":"WELDING GMBH & CO.KG","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"ACME GENERICS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"4470","totalValueFC":"101026.9","currency":"EUR","unitRateINR":"423309","date":"30-Sep-2024","totalValueINR":"8466180","totalValueInUsd":"101026.9","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"5873405","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"POST BOX 30 58 40, 20318, HAMBURG E SPLANADE 39, 20354 HAMBURG Hamburg, , GERMANY GERMANY","customerAddress":"PLOT NO 75 INDUSTRIAL AREA PHASE -"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"LEVOTHYROXINE SODIUM EP\/BP\/IP\/USP\/PH.EUR. (LEVOTHYROXINE SODIUM MILLED 119320)","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"2.50","actualQuantity":"2499","unit":"GMS","unitRateFc":"7.2","totalValueFC":"18906.1","currency":"USD","unitRateINR":"635.7","date":"18-Oct-2024","totalValueINR":"1588616.76","totalValueInUsd":"18906.1","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"6185496","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 SOUTH PARAMUS ROAD, SUITE 565 PARAMUS, NEW JERSEY 07652 UNITED STATES","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"LEVOTHYROXINE SODIUM EP\/BP\/IP\/USP\/PH.EUR. (LEVOTHYROXINE SODIUM MILLED 119320)","address":"2ND FLOOR, CHINUBHAI CENTRE,,OFF.","city":"AHMEDABAD,GUJARAT","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"102","unit":"GMS","unitRateFc":"7.2","totalValueFC":"771.7","currency":"USD","unitRateINR":"635.7","date":"18-Oct-2024","totalValueINR":"64841.5","totalValueInUsd":"771.7","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"6185496","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 SOUTH PARAMUS ROAD, SUITE 565 PARAMUS, NEW JERSEY 07652 UNITED STATES","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,,OFF."},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"LEVOTHYROXINE SODIUM EP\/BP\/IP\/USP\/PH.EUR. (LEVOTHYROXINE SODIUM MILLED 119320)","address":"2ND FLOOR, CHINUBHAI CENTRE,,OFF.","city":"AHMEDABAD,GUJARAT","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.05","actualQuantity":"1045","unit":"GMS","unitRateFc":"7.2","totalValueFC":"7905.9","currency":"USD","unitRateINR":"635.7","date":"18-Oct-2024","totalValueINR":"664307.53","totalValueInUsd":"7905.9","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"6185496","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 SOUTH PARAMUS ROAD, SUITE 565 PARAMUS, NEW JERSEY 07652 UNITED STATES","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,,OFF."},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"LEVOTHYROXINE SODIUM EP\/BP\/IP\/USP\/PH.EUR. (LEVOTHYROXINE SODIUM MILLED 119320)","address":"2ND FLOOR, CHINUBHAI CENTRE,,OFF.","city":"AHMEDABAD,GUJARAT","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.22","actualQuantity":"1224","unit":"GMS","unitRateFc":"7.2","totalValueFC":"9260.1","currency":"USD","unitRateINR":"635.7","date":"18-Oct-2024","totalValueINR":"778098","totalValueInUsd":"9260.1","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"6185496","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 SOUTH PARAMUS ROAD, SUITE 565 PARAMUS, NEW JERSEY 07652 UNITED STATES","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,,OFF."},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"LEVOTHYROXINE SODIUM EP\/BP\/IP\/USP\/PH.EUR. (LEVOTHYROXINE SODIUM MILLED 119320)","address":"2ND FLOOR, CHINUBHAI CENTRE,,OFF.","city":"AHMEDABAD,GUJARAT","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.75","actualQuantity":"1750","unit":"GMS","unitRateFc":"7.2","totalValueFC":"13239.6","currency":"USD","unitRateINR":"635.7","date":"18-Oct-2024","totalValueINR":"1112476.72","totalValueInUsd":"13239.6","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"6185496","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 SOUTH PARAMUS ROAD, SUITE 565 PARAMUS, NEW JERSEY 07652 UNITED STATES","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,,OFF."},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"LEVOTHYROXINE SODIUM EP\/BP\/IP\/USP\/PH.EUR. (LEVOTHYROXINE SODIUM MILLED 119320)","address":"2ND FLOOR, CHINUBHAI CENTRE,,OFF.","city":"AHMEDABAD,GUJARAT","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"2.50","actualQuantity":"2499","unit":"GMS","unitRateFc":"7.2","totalValueFC":"18906.1","currency":"USD","unitRateINR":"635.7","date":"18-Oct-2024","totalValueINR":"1588616.76","totalValueInUsd":"18906.1","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"6185496","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 SOUTH PARAMUS ROAD, SUITE 565 PARAMUS, NEW JERSEY 07652 UNITED STATES","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,,OFF."},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"LEVOTHYROXINE SODIUM EP\/BP\/IP\/USP\/PH.EUR. (LEVOTHYROXINE SODIUM MILLED 119320)","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"2.75","actualQuantity":"2754","unit":"GMS","unitRateFc":"7.2","totalValueFC":"20835.3","currency":"USD","unitRateINR":"635.7","date":"18-Oct-2024","totalValueINR":"1750720.51","totalValueInUsd":"20835.3","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"6185496","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 SOUTH PARAMUS ROAD, SUITE 565 PARAMUS, NEW JERSEY 07652 UNITED STATES","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"LEVOTHYROXINE SODIUM EP\/BP\/IP\/USP\/PH.EUR. (LEVOTHYROXINE SODIUM MILLED 119320)","address":"2ND FLOOR, CHINUBHAI CENTRE,,OFF.","city":"AHMEDABAD,GUJARAT","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"3998","unit":"GMS","unitRateFc":"7.2","totalValueFC":"30246.8","currency":"USD","unitRateINR":"635.7","date":"18-Oct-2024","totalValueINR":"2541532.53","totalValueInUsd":"30246.8","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"6185496","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 SOUTH PARAMUS ROAD, SUITE 565 PARAMUS, NEW JERSEY 07652 UNITED STATES","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,,OFF."}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

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INTERMEDIATES SUPPLIERS

01

Louis Pharmaceuticals

India

euroPLX 86 Munich

Not Confirmed

Not Confirmed

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FDF Dossiers

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FDA Orange Book

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Europe

01

Aspen Pharma Trading Limited,

Netherlands

CPhI India 2024

Attending

Aspen API. More than just an API.

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Netherlands

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Sweden

levothyroxine sodium (hydrate)

Brand Name : Eltroxin

Dosage Form : TABLET

Dosage Strength : 125 MICROGRAMS

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Product Web Link

02

Aspen Pharma Trading Limited,

Netherlands

CPhI India 2024

Attending

Aspen API. More than just an API.

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Netherlands

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Sweden

levothyroxine sodium (hydrate)

Brand Name : Eltroxin

Dosage Form : TABLET

Dosage Strength : 150 MICROGRAM

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Product Web Link

03

Aspen Pharma Trading Limited,

Netherlands

CPhI India 2024

Attending

Aspen API. More than just an API.

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Netherlands

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Sweden

levothyroxine sodium (hydrate)

Brand Name : Eltroxin

Dosage Form : TABLET

Dosage Strength : 75 MICROGRAMS

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Product Web Link

04

Aspen Pharma Trading Limited,

Netherlands

CPhI India 2024

Attending

Aspen API. More than just an API.

Contact Supplier

Netherlands

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Sweden

levothyroxine sodium (hydrate)

Brand Name : Eltroxin

Dosage Form : TABLET

Dosage Strength : 100 MICROGRAMS

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Product Web Link

05

Aspen Pharma Trading Limited,

Netherlands

CPhI India 2024

Attending

Aspen API. More than just an API.

Contact Supplier

Netherlands

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Sweden

levothyroxine sodium (hydrate)

Brand Name : Eltroxin

Dosage Form : TABLET

Dosage Strength : 175 MICROGRAMS

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Product Web Link

06

Aspen Pharma Trading Limited,

Netherlands

CPhI India 2024

Attending

Aspen API. More than just an API.

Contact Supplier

Netherlands

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Sweden

levothyroxine sodium (hydrate)

Brand Name : Eltroxin

Dosage Form : TABLET

Dosage Strength : 200 MICROGRAM

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Product Web Link

07

Aspen Pharma Trading Limited,

Netherlands

CPhI India 2024

Attending

Aspen API. More than just an API.

Contact Supplier

Netherlands

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Sweden

levothyroxine sodium (hydrate)

Brand Name : Eltroxin

Dosage Form : TABLET

Dosage Strength : 50 G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Product Web Link

08

Aspen Pharma Trading Limited,

Netherlands

CPhI India 2024

Attending

Aspen API. More than just an API.

Contact Supplier

Netherlands

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Sweden

levothyroxine sodium (hydrate)

Brand Name : Eltroxin

Dosage Form : TABLET

Dosage Strength : 25 MICROGRAMS

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Product Web Link

09

IBSA Institut Biochimique SA

Switzerland

Pharmtech & Ingredients

Not Confirmed

10

Merck Germany

France

Pharmtech & Ingredients

Not Confirmed

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Canada

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Australia

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South Africa

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 0.0125MG;0.0031MG

USFDA APPLICATION NUMBER - 16807

DOSAGE - TABLET;ORAL - 0.025MG;0.0063MG

USFDA APPLICATION NUMBER - 16807

DOSAGE - TABLET;ORAL - 0.05MG;0.0125MG

USFDA APPLICATION NUMBER - 16807

DOSAGE - TABLET;ORAL - 0.15MG;0.0375MG

USFDA APPLICATION NUMBER - 16807

DOSAGE - TABLET;ORAL - 0.1MG;0.025MG

USFDA APPLICATION NUMBER - 16807

DOSAGE - POWDER;INTRAVENOUS - 100MCG/VIAL

USFDA APPLICATION NUMBER - 202231

DOSAGE - POWDER;INTRAVENOUS - 200MCG/VIAL

USFDA APPLICATION NUMBER - 202231

DOSAGE - POWDER;INTRAVENOUS - 500MCG/VIAL

USFDA APPLICATION NUMBER - 202231

DOSAGE - TABLET;ORAL - 0.025MG **See current ...DOSAGE - TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21116

DOSAGE - TABLET;ORAL - 0.05MG **See current A...DOSAGE - TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21116

DOSAGE - TABLET;ORAL - 0.075MG **See current ...DOSAGE - TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21116

DOSAGE - TABLET;ORAL - 0.088MG **See current ...DOSAGE - TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21116

DOSAGE - TABLET;ORAL - 0.112MG **See current ...DOSAGE - TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21116

DOSAGE - TABLET;ORAL - 0.125MG **See current ...DOSAGE - TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21116

DOSAGE - TABLET;ORAL - 0.137MG **See current ...DOSAGE - TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21116

DOSAGE - TABLET;ORAL - 0.15MG **See current A...DOSAGE - TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21116

DOSAGE - TABLET;ORAL - 0.175MG **See current ...DOSAGE - TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21116

DOSAGE - TABLET;ORAL - 0.1MG **See current An...DOSAGE - TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21116

DOSAGE - TABLET;ORAL - 0.2MG **See current An...DOSAGE - TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21116

DOSAGE - TABLET;ORAL - 0.3MG **See current An...DOSAGE - TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21116

DOSAGE - TABLET;ORAL - 0.025MG **See current ...DOSAGE - TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21210

DOSAGE - TABLET;ORAL - 0.05MG **See current A...DOSAGE - TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21210

DOSAGE - TABLET;ORAL - 0.075MG **See current ...DOSAGE - TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21210

DOSAGE - TABLET;ORAL - 0.088MG **See current ...DOSAGE - TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21210

DOSAGE - TABLET;ORAL - 0.112MG **See current ...DOSAGE - TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21210

DOSAGE - TABLET;ORAL - 0.125MG **See current ...DOSAGE - TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21210

DOSAGE - TABLET;ORAL - 0.137MG **See current ...DOSAGE - TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21210

DOSAGE - TABLET;ORAL - 0.15MG **See current A...DOSAGE - TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21210

DOSAGE - TABLET;ORAL - 0.175MG **See current ...DOSAGE - TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21210

DOSAGE - TABLET;ORAL - 0.1MG **See current An...DOSAGE - TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21210

DOSAGE - TABLET;ORAL - 0.2MG **See current An...DOSAGE - TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21210

DOSAGE - TABLET;ORAL - 0.3MG **See current An...DOSAGE - TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21210

DOSAGE - TABLET;ORAL - 0.025MG **See current ...DOSAGE - TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21402

DOSAGE - TABLET;ORAL - 0.05MG **See current A...DOSAGE - TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21402

DOSAGE - TABLET;ORAL - 0.075MG **See current ...DOSAGE - TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21402

DOSAGE - TABLET;ORAL - 0.088MG **See current ...DOSAGE - TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21402

DOSAGE - TABLET;ORAL - 0.112MG **See current ...DOSAGE - TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21402

DOSAGE - TABLET;ORAL - 0.125MG **See current ...DOSAGE - TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21402

DOSAGE - TABLET;ORAL - 0.137MG **See current ...DOSAGE - TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21402

DOSAGE - TABLET;ORAL - 0.15MG **See current A...DOSAGE - TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21402

DOSAGE - TABLET;ORAL - 0.175MG **See current ...DOSAGE - TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21402

DOSAGE - TABLET;ORAL - 0.1MG **See current An...DOSAGE - TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21402

DOSAGE - TABLET;ORAL - 0.2MG **See current An...DOSAGE - TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21402

DOSAGE - TABLET;ORAL - 0.3MG **See current An...DOSAGE - TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

USFDA APPLICATION NUMBER - 21402

DOSAGE - CAPSULE;ORAL - 0.013MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.025MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.0375MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.044MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.05MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.0625MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.075MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.088MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.112MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.125MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.137MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.15MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.175MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.1MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.2MG

USFDA APPLICATION NUMBER - 21924

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FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments

This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (OPOE list). The list is a crucial resource for promoting competition and affordability in the pharmaceutical industry. Updated biannually in December and June, the OPOE list serves as a transparent guide for drug manufacturers. Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs). ANDAs are a streamlined pathway for generic drug development, offering a more cost-effective alternative to brand-name drugs. By highlighting drugs that lack generic competition on the OPOE list, FDA aims to incentivize manufacturers to develop generics, ultimately leading to greater affordability and access for patients. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) ALS drugs, cancer, asthma, HIV treatments among new drugs added to OPOE list The December 2023 OPOE list had 23 new applications of branded drugs eligible for but without generic competition. The June list further added 21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder). Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms). The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat. The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product. The agency considers first generics to be important to public health and prioritizes review of these submissions. First generics are eligible for a 180-day exclusivity period. Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal chromosome in their blood cells called the Philadelphia chromosome), got its first generic in January, which was introduced by Apotex. Tasigna brought in sales of US$ 1.85 billion in 2023 and its sales are projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in April. Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved drug to treat tardive dyskinesia, a disorder that involves involuntary movements. It raked in US$ 1.84 billion in 2023, registering a year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) Our view The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or a democrat takes over the US administration, making medicines affordable should remain a priority. In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.

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Levothyroxine

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ACTIVE PHARMA INGREDIENTS

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DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.0125MG;0.0031MG

TABLET;ORAL - 0.025MG;0.0063MG

TABLET;ORAL - 0.05MG;0.0125MG

TABLET;ORAL - 0.15MG;0.0375MG

TABLET;ORAL - 0.1MG;0.025MG

POWDER;INTRAVENOUS - 100MCG/VIAL

POWDER;INTRAVENOUS - 200MCG/VIAL

POWDER;INTRAVENOUS - 500MCG/VIAL

TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

CAPSULE;ORAL - 0.013MG

CAPSULE;ORAL - 0.025MG

CAPSULE;ORAL - 0.0375MG

CAPSULE;ORAL - 0.044MG

CAPSULE;ORAL - 0.05MG

CAPSULE;ORAL - 0.0625MG

CAPSULE;ORAL - 0.075MG