Clavulanic Acid

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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

FINISHED DOSAGE FORMULATIONS

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TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL -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EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

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

GLOBAL SALES INFORMATION

309 Finished Drug Prices, 5 Annual Reports

MARKET PLACE

49 APIs, 9 FDF Dossiers

REF. STANDARDS & IMPURITIES

4 EDQM, 4 Others

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USFDA APPLICATION NUMBER - 50564 / DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
amoxicillin(UNII: 804826J2HU) (amoxicillin - UNII:804826J2HU)	amoxicillin	500mg
clavulanate potassium(UNII: Q42OMW3AT8) (clavulanic acid - UNII:23521W1S24)	clavulanate potassium	125mg

Inactive Ingredients

Ingredient Name	Neopharma Inc	Cardinal Health	Preferred Pharmaceuticals, Inc.
ASPARTAME(Z0H242BBR1)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
SACCHARIN SODIUM(SB8ZUX40TY)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
TITANIUM DIOXIDE(15FIX9V2JP)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Clavulanic Acid

Clavulanic Acid

Clavulanic Acid

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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

FINISHED DOSAGE FORMULATIONS

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**

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

EXCIPIENTS BY APPLICATIONS

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

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