DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

44 API Suppliers, 25 USDMF, 34 CEP/COS, 61 KDMF, 14 NDC API, 11 Listed Suppliers, $ API Reference Price

44 API Suppliers
25 USDMF
34 CEP/COS
61 KDMF
14 NDC API
11 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

641 FDF Dossiers, 73 FDA Orange Book, 337 Europe, 105 South Africa, 126 Listed Dossiers

641 FDF Dossiers
73 FDA Orange Book
337 Europe
105 South Africa
126 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL - 875MG;EQ 125MG BASE, FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML, FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML, FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML
FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML
TABLET;ORAL - 875MG;EQ 125MG BASE
FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML
FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML
FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML
TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Evonik, 5 Rochem International Inc, 13 SPI Pharma, 2 Seqens, 14 DKSH, 1 Pharm-RX Chemical, 5 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 31 BASF, 2 Clariant, 11 Corel Pharma Chem, 4 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 17 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 16 Roquette, 12 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

relatedExcipients
1 Evonik
5 Rochem International Inc
13 SPI Pharma
2 Seqens
14 DKSH
1 Pharm-RX Chemical
5 Faran Shimi Pharmaceutical
5 Boai NKY Pharmaceuticals Ltd
9 Gangwal Healthcare
6 Nanjing Well Pharmaceutical
1 Pfanstiehl
1 ACG Worldwide
6 Actylis
1 Aeon Procare
1 Alcedo Pharmachem
8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 Avesta Pharma
31 BASF
2 Clariant
11 Corel Pharma Chem
4 DFE Pharma
2 Finar
11 Gangwal Chemicals
5 Ideal Cures Pvt Ltd
3 Ingredion Pharma Solutions
17 Kerry
5 Kima Chemical
6 Lonza Capsugel
16 Microlex e.U
1 Nanjing Bold Chemical
2 Nomisma Healthcare
3 Novo Excipients
4 Pharmatrans-Sanaq
6 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
16 Roquette
12 Seppic
5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
11 Sigachi Industries
4 The Dow Chemical Company
1 Ulanqab Kema New Material
1 Valens Pharmachem
4 Vasa Pharmachem
1 Vertellus

EXCIPIENTS BY APPLICATIONS

64 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 38 Disintegrants & Superdisintegrants, 35 Direct Compression, 35 Thickeners and Stabilizers, 32 Controlled & Modified Release, 31 Solubilizers, 27 Granulation, 22 Topical, 21 Taste Masking, 21 Film Formers & Plasticizers, 18 Parenteral, 18 Lubricants & Glidants, 15 Chewable & Orodispersible Aids, 14 Co-Processed Excipients, 10 Rheology Modifiers, 9 Emulsifying Agents, 7 API Stability Enhancers, 6 Surfactant & Foaming Agents, 5 Empty Capsules, 4 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 14 NEWS #PharmaBuzz

media
3 DATA COMPILATION #PharmaFlow
14 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

309 Finished Drug Prices, 5 Annual Reports

globalSalesInformation
309 Finished Drug Prices
5 Annual Reports

MARKET PLACE

49 APIs, 9 FDF Dossiers

marketPlace
49 APIs
9 FDF Dossiers

REF. STANDARDS & IMPURITIES

4 EDQM , 4 Others

otherSolutions
4 EDQM
4 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 79

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

641

FDF Dossiers

FDA Orange Book

337

Europe

Canada

Australia

105

South Africa

126

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)

Annual Reports (USD Million)

3,390

Finished Drug Prices

271 RELATED EXCIPIENT COMPANIES

487EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Potassium clavulanate, 61177-45-5, Clavulanic acid potassium salt, Brl 14151k, Clavulanate (potassium), Q42omw3at8

Molecular Formula

C₈H₈KNO₅

Molecular Weight

237.25 g/mol

InChI Key

ABVRVIZBZKUTMK-JSYANWSFSA-M

FDA UNII

Q42OMW3AT8

A beta-lactam antibiotic produced by the actinobacterium Streptomyces clavuligerus. It is a suicide inhibitor of bacterial beta-lactamase enzymes. Administered alone, it has only weak antibacterial activity against most organisms, but given in combination with other beta-lactam antibiotics it prevents antibiotic inactivation by microbial lactamase.

1 2D Structure

Clavulanic Acid

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

potassium;(2R,3Z,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

2.1.2 InChI

InChI=1S/C8H9NO5.K/c10-2-1-4-7(8(12)13)9-5(11)3-6(9)14-4;/h1,6-7,10H,2-3H2,(H,12,13);/q;+1/p-1/b4-1-;/t6-,7-;/m1./s1

2.1.3 InChI Key

ABVRVIZBZKUTMK-JSYANWSFSA-M

2.1.4 Canonical SMILES

C1C2N(C1=O)C(C(=CCO)O2)C(=O)[O-].[K+]

2.1.5 Isomeric SMILES

C1[C@@H]2N(C1=O)[C@H](/C(=C/CO)/O2)C(=O)[O-].[K+]

2.2 Other Identifiers

2.2.1 UNII

Q42OMW3AT8

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Brl 14151

2. Brl-14151

3. Brl14151

4. Clavulanate

5. Clavulanate, Potassium

6. Clavulanate, Sodium

7. Clavulanic Acid

8. Clavulanic Acid, Monopotassium Salt

9. Clavulanic Acid, Monosodium Salt

10. Mm 14151

11. Mm-14151

12. Mm14151

13. Potassium Clavulanate

14. Potassium, Clavulanate

15. Sodium Clavulanate

2.3.2 Depositor-Supplied Synonyms

1. Potassium Clavulanate

2. 61177-45-5

3. Clavulanic Acid Potassium Salt

4. Brl 14151k

5. Clavulanate (potassium)

6. Q42omw3at8

7. Chebi:85264

8. Brl-14151k

9. Potassium (2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

10. Potassium (z)-(2r,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylate

11. Potassium;(2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

12. Amonate

13. Potassium (2r,5r,z)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

14. Clavulansaeure Kaliumsalz

15. Einecs 262-640-9

16. Unii-q42omw3at8

17. Potassium Clavlanate

18. Clavulanate Potassium [usan:usp:jan]

19. Chembl1003

20. Schembl203411

21. Clavulanic Acid Potassium

22. Hy-a0256a

23. Dtxsid60210067

24. Hms3715b13

25. Clavulanate Potassium (jp17/usp)

26. Potassium Clavulanate [jan]

27. Bcp13548

28. Clavulanate Potassium [usan]

29. Clavulanate Potassium [vandf]

30. Potassium Clavulanate [mart.]

31. Potassium Clavulanate Cellulose(1:1)

32. Akos015961326

33. Clavulanate Potassium [who-dd]

34. Ccg-221126

35. 4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3-(2-hydroxyethylidene)-7-oxo-, Monopotassium Salt, (2r-(2alpha,3z,5alpha))-

36. Ac-13551

37. Bp-30181

38. Clavulanate Potassium [green Book]

39. Potassium (2r-(2alpha,3z,5alpha))-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylate

40. Clavulanate Potassium [orange Book]

41. Potassium Clavulanate [ep Monograph]

42. Clavulanate Potassium [usp Monograph]

43. Cs-0019771

44. Augmentin Component Clavulanate Potassium

45. C-6660

46. Clavulox Component Clavulanate Potassium

47. D02370

48. D84066

49. Timentin Component Clavulanate Potassium

50. A833076

51. Clavulanate Potassium Component Of Augmentin

52. Clavulanate Potassium Component Of Clavulox

53. Clavulanate Potassium Component Of Timentin

54. Clavulanic Acid (as Clavulanate Potassium)

55. Clavulanic Acid Potassium 100 Microg/ml In Water

56. W-105420

57. Clavulanate Potassium+microcrystalline Cellulose(1:1)

58. Potassium Clavulanate (40%) : Silicon Dioxide Mixture

59. Q27158444

60. Potassium Clavulanate (50%) : Microcrystalline Cellulose

61. Clavulanate Potassium Salt, Antibiotic For Culture Media Use Only

62. Potassium Clavulanate - 1:1 Mixture With Cellulose, Antibiotic For Culture Media Use Only

63. (2r,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2beta-carboxylic Acid Potassium Salt

64. 4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3-(2-hydroxyethylidene)-7-oxo-, Monopotassium Salt, (2r-(2.alpha.,3z,5.alpha.))-

65. Potassium (2r,3z,5r)-3-(2-oxidanylethylidene)-7-oxidanylidene-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

66. Potassium (2r,5r,z)- 3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

67. Potassium(2r,5r,z)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

2.4 Create Date

2008-02-05

3 Chemical and Physical Properties

Molecular Formula	C₈H₈KNO₅
Molecular Weight	237.25 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	2
Exact Mass	237.00395384 g/mol
Monoisotopic Mass	237.00395384 g/mol
Topological Polar Surface Area	89.9 Å²
Heavy Atom Count	15
Formal Charge	0
Complexity	329
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	1
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Pharmacology and Biochemistry

4.1 MeSH Pharmacological Classification

beta-Lactamase Inhibitors

Endogenous substances and drugs that inhibit or block the activity of BETA-LACTAMASES. (See all compounds classified as beta-Lactamase Inhibitors.)

API SUPPLIERS

01

Centrient Pharmaceuticals

Netherlands

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

Contact Supplier

Netherlands

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Not Available For Sales AUDIT

02

Rochem International Inc

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Suppliers Night Expo

Attending

Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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U.S.A

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF VMF

AUDIT

03

Capital Farma

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.

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Spain

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Corporate PDF

04

Lunan Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Lunan Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

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05

Lunan Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Lunan Pharmaceutical

China

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Not Confirmed

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08

Sinopharm Weiqida Pharmaceutical C...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Sinopharm Weiqida Pharmaceutical C...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

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USDMF

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JDMF EU-WC NDC

KDMF

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09

Lek Pharmaceuticals

Slovenia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Lek Pharmaceuticals

Slovenia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

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KDMF

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10

Lek Pharmaceuticals

Slovenia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Lek Pharmaceuticals

Slovenia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Not Confirmed

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CEP/COS

01

Fermic SA de CV Iztapalapa MX

Mexico

Medlab Asia & Asia Health

Not Confirmed

02

Fermic SA de CV Iztapalapa MX

Mexico

Medlab Asia & Asia Health

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Not Confirmed

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API Reference Price

[{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714933800,"product":"INTERMEDIATE FOR MANUFACTURING OF ACTIVE PHARMACUETICAL INGREDIENTS CLAVULANIC ACID TERTIARY BUTYLAMINE SALTE (TBA)","address":"202\/C, SAI DHAM CO-OP. HSG. SOC.,","city":"MULUND (W) MUMBAI, MAHARASHTRA","supplier":"M\/S","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON","customer":"DPB ANTIBIOTICS","customerCountry":"INDIA","quantity":"960.00","actualQuantity":"960","unit":"KGS","unitRateFc":"125","totalValueFC":"121433.6","currency":"USD","unitRateINR":"10543.8","date":"06-May-2024","totalValueINR":"10122000","totalValueInUsd":"121433.6","indian_port":"JNPT","hs_no":"29349990","bill_no":"3347219","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON","supplierAddress":"CAPITAL FARMA INVEST CAPITAL FARMAS L AVENNIDA DE LA TRANSICION ESPANOLA 24 PLANTA 1 EDIFICIO GAMMA ALCO SPAIN","customerAddress":"202\/C, SAI DHAM CO-OP. HSG. SOC.,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719599400,"product":"INTERMEDIATE FOR MANUFACTURING OF ACTIVE PHARMACUETICAL INGREDIENTS CLAVULANIC ACID TERTIARY BUTYLAMINE SALTE (TBA)","address":"202\/C, SAI DHAM CO-OP. HSG. SOC.,","city":"MULUND (W) MUMBAI, MAHARASHTRA","supplier":"M\/S","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON GATWAY PORT","customer":"DPB ANTIBIOTICS","customerCountry":"INDIA","quantity":"1240.00","actualQuantity":"1240","unit":"KGS","unitRateFc":"114.8","totalValueFC":"143751.3","currency":"USD","unitRateINR":"9677.6","date":"29-Jun-2024","totalValueINR":"12000273.6","totalValueInUsd":"143751.3","indian_port":"JNPT","hs_no":"29349990","bill_no":"4241655","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON GATWAY PORT","supplierAddress":"CAPITAL FARMA INVEST CAPITAL FARMAS L AVENNIDA DE LA TRANSICION ESPANOLA 24 PLANTA 1 EDIFICIO GAMMA ALCO SPAIN","customerAddress":"202\/C, SAI DHAM CO-OP. HSG. SOC.,"}]

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 - 250MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50564

DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50564

DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 3...DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML

USFDA APPLICATION NUMBER - 50575

DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 6...DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML

USFDA APPLICATION NUMBER - 50575

DOSAGE - TABLET;ORAL - 875MG;EQ 125MG BASE

USFDA APPLICATION NUMBER - 50720

DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 2...DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML

USFDA APPLICATION NUMBER - 50725

DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 5...DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML

USFDA APPLICATION NUMBER - 50725

DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 4...DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML

USFDA APPLICATION NUMBER - 50755

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50785

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