FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

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AUGMENTIN ES-600-1

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ACTIVE PHARMA INGREDIENTS

78 API Suppliers, 25 USDMF, 36 CEP/COS, 60 KDMF, 14 NDC API, 11 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1058 FDF Dossiers, 73 FDA Orange Book, 625 Europe, 60 Australia, 110 South Africa, 190 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TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL -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SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 14 SPI Pharma, 1 Pharm-RX Chemical, 5 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 6 Kirsch Pharma, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Ashland, 1 Avesta Pharma, 31 BASF, 2 CD Formulation, 2 Clariant, 11 Corel Pharma Chem, 4 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 1 Gloria Interchem, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 11 Kerry, 4 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 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 Silverline Chemicals, 4 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

57 Fillers, Diluents & Binders, 45 Coating Systems & Additives, 42 Disintegrants & Superdisintegrants, 35 Thickeners and Stabilizers, 31 Solubilizers, 29 Direct Compression, 27 Controlled & Modified Release, 27 Granulation, 23 Taste Masking, 22 Parenteral, 22 Topical, 20 Film Formers & Plasticizers, 18 Chewable & Orodispersible Aids, 17 Lubricants & Glidants, 10 Co-Processed Excipients, 8 Emulsifying Agents, 8 Rheology Modifiers, 7 Surfactant & Foaming Agents, 6 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 2 Coloring Agents

DIGITAL CONTENT

18 News #PharmaBuzz

18 News #PharmaBuzz

GLOBAL SALES INFORMATION

13 US Medicaid Prescriptions, 239 Regulatory FDF Prices, 11 Annual Reports

MARKET PLACE

52 APIs, 9 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 Health Canada Patents

2 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 12 USP, 4 Others

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Certificate Holder	Certificate No.	Substance	Issue Date	Status	Type	End Date	Substance No.
29/01/2026	CKD Bio Corporation	South Korea	CKD BIO CORPORATION Ansan-si KR	R1-CEP 2005-179 - Rev 03	Potassium clavulanate, diluted, with microcrystalline cellulose in the ratio 1:1	2017-02-09	Valid	Chemical and TSE		1653
29/01/2026	CKD Bio Corporation	South Korea	CKD BIO CORPORATION Ansan-si KR	CEP 2003-183 - Rev 05	Potassium clavulanate	2025-08-06	Valid	Chemical and TSE		1140

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

AUGMENTIN ES-600-1

AUGMENTIN ES-600-1

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

78 API Suppliers

25 USDMF

36 CEP/COS

60 KDMF

14 NDC API

11 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1058 FDF Dossiers

73 FDA Orange Book

625 Europe

60 Australia

110 South Africa

190 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

14 SPI Pharma

1 Pharm-RX Chemical

5 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Pfanstiehl

6 Kirsch Pharma

1 ACG Worldwide

6 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

4 Ashland

1 Avesta Pharma

31 BASF

2 CD Formulation

2 Clariant

11 Corel Pharma Chem

4 DFE Pharma

1 Esteem Industries

2 Finar

11 Gangwal Chemicals

1 Gloria Interchem

4 Ideal Cures

3 Ingredion Pharma Solutions

11 Kerry

4 Keval Exports

5 Kima Chemical

6 Lonza Capsugel

16 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

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 Silverline Chemicals

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 - 200MG/5ML;EQ 28.5MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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