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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 16 USDMF, 12 CEP/COS, 9 JDMF, 3 EU WC, 9 KDMF, 5 NDC API, 9 Listed Suppliers, $ API Reference Price

26 API Suppliers
16 USDMF
12 CEP/COS
9 JDMF
3 EU WC
9 KDMF
5 NDC API
9 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

448 FDF Dossiers, 78 FDA Orange Book, 234 Europe, 51 Canada, 42 Australia, 27 South Africa, 16 Listed Dossiers

448 FDF Dossiers
78 FDA Orange Book
234 Europe
51 Canada
42 Australia
27 South Africa
16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 23 SPI Pharma, 3 DKSH, 7 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 13 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 2 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 21 BASF, 11 Corel Pharma Chem, 6 DFE Pharma, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 4 Vasa Pharmachem

relatedExcipients
1 Minakem
1 Rochem International Inc
23 SPI Pharma
3 DKSH
7 Faran Shimi Pharmaceutical
8 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
13 Gangwal Healthcare
3 Nanjing Well Pharmaceutical
1 Pfanstiehl
1 ACG Worldwide
2 Aeon Procare
2 Alcedo Pharmachem
10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
21 BASF
11 Corel Pharma Chem
6 DFE Pharma
10 Gangwal Chemicals
5 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
37 Kerry
3 Kima Chemical
6 Lonza Capsugel
17 Microlex e.U
1 Nanjing Bold Chemical
1 NEWEDGE Overseas
3 Novo Excipients
4 Pharmatrans-Sanaq
7 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
18 Roquette
7 Seppic
8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
11 Sigachi Industries
2 The Dow Chemical Company
2 Ulanqab Kema New Material
4 Vasa Pharmachem

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89 Fillers, Diluents & Binders, 49 Direct Compression, 47 Coating Systems & Additives, 35 Disintegrants & Superdisintegrants, 30 Granulation, 28 Lubricants & Glidants, 25 Controlled & Modified Release, 23 Co-Processed Excipients, 20 Thickeners and Stabilizers, 20 Chewable & Orodispersible Aids, 17 Taste Masking, 14 Solubilizers, 10 API Stability Enhancers, 9 Parenteral, 9 Film Formers & Plasticizers, 6 Emulsifying Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Topical, 3 Rheology Modifiers, 2 Surfactant & Foaming Agents

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20 NEWS #PharmaBuzz

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20 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 228 Finished Drug Prices, 1 Annual Reports

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1 US Medicaid Prescriptions
228 Finished Drug Prices
1 Annual Reports

MARKET PLACE

8 APIs, 2 FDF Dossiers

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8 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

patents
4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 4 USP , 6 JP , 5 Others

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3 EDQM
4 USP
6 JP
5 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 619

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

448

FDF Dossiers

FDA Orange Book

234

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

176,484,779

Annual Reports (USD Million)

106

Finished Drug Prices

272 RELATED EXCIPIENT COMPANIES

452EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 81131-70-6, Pravachol, Mevalotin, Selektine, Elisor, Pravaselect

Molecular Formula

C₂₃H₃₅NaO₇

Molecular Weight

446.5 g/mol

InChI Key

VWBQYTRBTXKKOG-IYNICTALSA-M

FDA UNII

3M8608UQ61

An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).

1 2D Structure

Pravastatin

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;(3R,5R)-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[(2S)-2-methylbutanoyl]oxy-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate

2.1.2 InChI

InChI=1S/C23H36O7.Na/c1-4-13(2)23(29)30-20-11-17(25)9-15-6-5-14(3)19(22(15)20)8-7-16(24)10-18(26)12-21(27)28;/h5-6,9,13-14,16-20,22,24-26H,4,7-8,10-12H2,1-3H3,(H,27,28);/q;+1/p-1/t13-,14-,16+,17+,18+,19-,20-,22-;/m0./s1

2.1.3 InChI Key

VWBQYTRBTXKKOG-IYNICTALSA-M

2.1.4 Canonical SMILES

CCC(C)C(=O)OC1CC(C=C2C1C(C(C=C2)C)CCC(CC(CC(=O)[O-])O)O)O.[Na+]

2.1.5 Isomeric SMILES

CC[C@H](C)C(=O)O[C@H]1C[C@@H](C=C2[C@H]1[C@H]([C@H](C=C2)C)CC[C@H](C[C@H](CC(=O)[O-])O)O)O.[Na+]

2.2 Other Identifiers

2.2.1 UNII

3M8608UQ61

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Apo Pravastatin

2. Apo-pravastatin

3. Bristacol

4. Cs 514

5. Cs-514

6. Cs514

7. Elisor

8. Eptastatin

9. Lin Pravastatin

10. Lin-pravastatin

11. Lipemol

12. Liplat

13. Lipostat

14. Mevalotin

15. Nu Pravastatin

16. Nu-pravastatin

17. Prareduct

18. Pravachol

19. Pravacol

20. Pravasin

21. Pravastatin

22. Pravastatin Monosodium Salt, (6 Beta)-isomer

23. Pravastatin Sodium Salt

24. Pravastatin Tert Octylamine Salt

25. Pravastatin Tert-octylamine Salt

26. Pravastatin, (6 Beta)-isomer

27. Rms 431

28. Rms-431

29. Rms431

30. Selektine

31. Sodium Salt, Pravastatin

32. Sq 31,000

33. Sq 31000

34. Sq-31,000

35. Sq-31000

36. Sq31,000

37. Sq31000

38. Vasten

2.3.2 Depositor-Supplied Synonyms

1. 81131-70-6

2. Pravachol

3. Mevalotin

4. Selektine

5. Elisor

6. Pravaselect

7. Lipostat

8. Eptastatin Sodium

9. Cs-514

10. Pravastatin Sodium Salt

11. Pravastatin (sodium)

12. Dehypotin Protect

13. Sq-31000

14. Sq-31,000

15. Chebi:8361

16. Bristacol

17. Lipemol

18. Prareduct

19. Pravacol

20. Pravasin

21. 3m8608uq61

22. Nsc-759253

23. Sodium;(3r,5r)-7-[(1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-[(2s)-2-methylbutanoyl]oxy-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate

24. Aplactin

25. Lipidal

26. Liprevil

27. Pralidon

28. Pravasine

29. Sanaprav

30. Selipran

31. Vasen

32. Epastatin Sodium

33. Dsstox_cid_27525

34. Dsstox_rid_82395

35. Dsstox_gsid_47525

36. Liplat

37. Vasten

38. Pravastatin, Sodium Salt

39. (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-(((s)-2-methylbutanoyl)oxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoic Acid, Sodium Salt

40. Cas-81131-70-6

41. Pravastatin Natrium Mayrho Fer

42. Sq 31000

43. 3-beta-hydroxycompactin Sodium Salt

44. Drg-0319

45. Chembl690

46. Unii-3m8608uq61

47. Cres Pravastatin

48. Pravachol (tn)

49. Ncgc00095183-01

50. Pravastatin Sodium [usan:usp:jan]

51. Mfcd00887601

52. Pravastatinsodium,(s)

53. Cs-514 Sodium

54. Pravastatin Sodium- Bio-x

55. Schembl3013

56. Sodium (+)-(betar,deltar,1s,2s,6s,8s,8ar)-1,2,6,7,8,8a-hexahydro-beta,delta,6,8-tetrahydroxy-2-methyl-1-naphthaleneheptanoate, 8-((2s)-2-methylbutyrate)

57. Pravastatin Sodium [mi]

58. Dtxsid6047525

59. Pravastatin Sodium [jan]

60. Hy-b0165a

61. Pravastatin Sodium (jp17/usp)

62. Pravastatin Sodium [usan]

63. Hms2051p05

64. Hms3268l20

65. Hms3413e20

66. Pravastatin Sodium [vandf]

67. Hexahydronaphthalen-1-yl)heptanoate

68. Pravastatin Sodium [mart.]

69. Amy40517

70. Pravastatin Sodium [usp-rs]

71. Pravastatin Sodium [who-dd]

72. Tox21_111474

73. Tox21_300270

74. S3036

75. Akos015896504

76. Akos015964902

77. Ccg-100926

78. Cs-2003

79. Nc00176

80. Nsc 759253

81. Pravastatin Sodium [orange Book]

82. Ncgc00092370-01

83. Ncgc00254232-01

84. Pravastatin Sodium [ep Monograph]

85. 1-naphthaleneheptanoic Acid, 1,2,6,7,8,8a-hexahydro-2-methyl-8-(2-methyl-1-oxobutoxy)-beta,delta,6-trihydroxy-, Monosodium Salt, (1s-(1-alpha(beta-s*,delta-s*),2-alpha,6-alpha,8-beta(r*),8a-alpha))-

86. 1-naphthaleneheptanoic Acid, 1,2,6,7,8,8a-hexahydro-beta,delta,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, Monosodium Salt, (1s-(1alpha(betas*,deltas*),2alpha,6alpha,8beta(r*),8aalpha))-

87. Bp164292

88. Pravastatin Sodium [usp Monograph]

89. P1796

90. D00893

91. Pravigard Pac Component Pravastatin Sodium

92. Pravastatin Sodium Component Of Pravigard Pac

93. Q27108059

94. Pravastatin Sodium Salt Hydrate, >=98% (hplc), Powder

95. 2-methyl-8-((s)-2-methylbutanoyloxy)-1,2,6,7,8,8a-

96. Sodium (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-

97. (?r,?r,1s,2s,6s,8s,8ar)-1,2,6,7,8,8a-hexahydro-?,?,6-trihydroxy-2-methyl-8-[(2s)-2-methyl-1-oxobutoxy]-1-naphthaleneheptanoic Acid Monosodium Salt

98. (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-(((s)-2-methylbutanoyl)oxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoicacid,sodiumsalt

99. 1-naphthaleneheptanoic Acid, 1,2,6,7,8,8a-hexahydro-.beta.,d,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, Monosodium Salt, (1s-(1.alpha.(.beta.s*,ds*),2.alpha.,6.alpha.,8.beta.(r*),8a.alpha.))-

100. Sodium (+)-(.beta.r,dr,1s,2s,6s,8s,8ar)-1,2,6,7,8,8a-hexahydro-.beta.,d,6,8-tetrahydroxy-2-methyl-1-naphthaleneheptanoate, 8-((2s)-2-methylbutyrate)

101. Sodium (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-((s)-2-methylbutanoyloxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoate

102. Sodium (3r,5r)-3,5-dihydroxy-7-[(1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-{[(2s)-2-methylbutanoyl]oxy}-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate

2.4 Create Date

2007-11-09

3 Chemical and Physical Properties

Molecular Formula	C₂₃H₃₅NaO₇
Molecular Weight	446.5 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	7
Rotatable Bond Count	11
Exact Mass	446.22804773 g/mol
Monoisotopic Mass	446.22804773 g/mol
Topological Polar Surface Area	127 Å²
Heavy Atom Count	31
Formal Charge	0
Complexity	662
Isotope Atom Count	0
Defined Atom Stereocenter Count	8
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Pravachol
PubMed Health	Pravastatin (By mouth)
Drug Classes	Antihyperlipidemic
Drug Label	PRAVACHOL (pravastatin sodium) is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in ch...
Active Ingredient	Pravastatin sodium
Dosage Form	Tablet
Route	Oral
Strength	10mg; 80mg; 40mg; 20mg
Market Status	Prescription
Company	Bristol Myers Squibb

2 of 4
Drug Name	Pravastatin sodium
Drug Label	Pravastatin sodium tablets are one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase,...
Active Ingredient	Pravastatin sodium
Dosage Form	Tablet
Route	oral; Oral
Strength	10mg; 80mg; 40mg; 20mg
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Teva; Lupin Pharms; Apotex; Sandoz; Cipla; Watson Labs; Glenmark Generics; Teva Pharms; Pliva Hrvatska Doo; Zydus Pharms Usa; Dr Reddys Labs; Mylan

3 of 4
Drug Name	Pravachol
PubMed Health	Pravastatin (By mouth)
Drug Classes	Antihyperlipidemic
Drug Label	PRAVACHOL (pravastatin sodium) is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in ch...
Active Ingredient	Pravastatin sodium
Dosage Form	Tablet
Route	Oral
Strength	10mg; 80mg; 40mg; 20mg
Market Status	Prescription
Company	Bristol Myers Squibb

4 of 4
Drug Name	Pravastatin sodium
Drug Label	Pravastatin sodium tablets are one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase,...
Active Ingredient	Pravastatin sodium
Dosage Form	Tablet
Route	oral; Oral
Strength	10mg; 80mg; 40mg; 20mg
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Teva; Lupin Pharms; Apotex; Sandoz; Cipla; Watson Labs; Glenmark Generics; Teva Pharms; Pliva Hrvatska Doo; Zydus Pharms Usa; Dr Reddys Labs; Mylan

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anticholesteremic Agents

Substances used to lower plasma cholesterol levels. (See all compounds classified as Anticholesteremic Agents.)

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Compounds that inhibit HYDROXYMETHYLGLUTARYL COA REDUCTASES. They have been shown to directly lower CHOLESTEROL synthesis. (See all compounds classified as Hydroxymethylglutaryl-CoA Reductase Inhibitors.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]; HMG-CoA Reductase Inhibitor [EPC]

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PRAVASTATIN SODIUM USP

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DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 14235

Submission : 1999-06-24

Status : Active

Type : II

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Pay. Date : 2012-11-13

DMF Number : 14729

Submission : 2000-02-25

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API Reference Price

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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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DOSAGE - TABLET;ORAL - 10MG **Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19898

DOSAGE - TABLET;ORAL - 20MG **Federal Registe...DOSAGE - TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19898

DOSAGE - TABLET;ORAL - 40MG **Federal Registe...DOSAGE - TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19898

DOSAGE - TABLET;ORAL - 80MG **Federal Registe...DOSAGE - TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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18 Roquette

7 Seppic

8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

2 The Dow Chemical Company

2 Ulanqab Kema New Material

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

89 Fillers, Diluents & Binders

49 Direct Compression

47 Coating Systems & Additives

35 Disintegrants & Superdisintegrants

30 Granulation

28 Lubricants & Glidants

25 Controlled & Modified Release

23 Co-Processed Excipients

20 Thickeners and Stabilizers

TABLET;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons