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

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Tazobactam Sodium

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ACTIVE PHARMA INGREDIENTS

34 API Suppliers, 18 USDMF, 10 JDMF, 2 EU WC, 2 KDMF, 8 NDC API, 9 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

288 FDF Dossiers, 60 FDA Orange Book, 138 Europe, 17 Canada, 12 South Africa, 61 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 40MG BASE/ML;EQ 5MG BASE/ML, INJECTABLE;INJECTION - EQ 4GM BASE/100ML;EQ 500MG BASE/100ML, INJECTABLE;INJECTION - EQ 60MG BASE/ML;EQ 7.5MG BASE/ML

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 1 Pfanstiehl, 5 Kirsch Pharma, 3 Actylis, 1 Pluviaendo, 4 Roquette

EXCIPIENTS BY APPLICATIONS

10 Parenteral, 2 Thickeners and Stabilizers, 2 API Stability Enhancers, 2 Fillers, Diluents & Binders

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 44 News #PharmaBuzz

GLOBAL SALES INFORMATION

23 US Medicaid Prescriptions, 17 Regulatory FDF Prices, 12 Annual Reports

MARKET PLACE

15 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

26 US Patents, 1 US Exclusivities, 6 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 Others

4 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
29/01/2026	ACS DOBFAR SPA	Italy	ACS DOBFAR SPA	34946	TAZOBACTAM SODIUM STERILE	2024-08-05	Active	II	N/A
29/01/2026	Aurobindo Pharma Limited	India	APITORIA PHARMA PRIVATE LTD	19823	TAZOBACTAM HEMIHYDRATE USP	2006-09-27	Active	II	Complete	2021-12-16	2021-12-13

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Tazobactam Sodium

Tazobactam Sodium

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

34 API Suppliers

18 USDMF

10 JDMF

2 EU WC

2 KDMF

8 NDC API

9 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

288 FDF Dossiers

60 FDA Orange Book

138 Europe

17 Canada

12 South Africa

61 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 40MG BASE/ML;EQ 5MG BASE/ML

INJECTABLE;INJECTION - EQ 4GM BASE/100ML;EQ 500MG BASE/100ML

INJECTABLE;INJECTION - EQ 60MG BASE/ML;EQ 7.5MG BASE/ML

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

1 Pfanstiehl

5 Kirsch Pharma

3 Actylis

1 Pluviaendo

4 Roquette

EXCIPIENTS BY APPLICATIONS

10 Parenteral

2 Thickeners and Stabilizers

2 API Stability Enhancers

2 Fillers, Diluents & Binders

DIGITAL CONTENT

2 Data Compilation #PharmaFlow

44 News #PharmaBuzz

GLOBAL SALES INFORMATION

23 US Medicaid Prescriptions

17 Regulatory FDF Prices

12 Annual Reports

MARKET PLACE

15 APIs

5 FDF Dossiers

PATENTS & EXCLUSIVITIES

26 US Patents

1 US Exclusivities

6 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 Others

Filters

INJECTABLE;INJECTION - EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons