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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. 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(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

02

Louis Pharmaceuticals

India

euroPLX 86 Munich

Not Confirmed

03

Novick Biosciences

India

euroPLX 86 Munich

Not Confirmed

04

Novick Biosciences

India

euroPLX 86 Munich

Not Confirmed

05

Scinvapharma

India

euroPLX 86 Munich

Not Confirmed

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FDF Dossiers

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FDA Orange Book

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Europe

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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