Is Cefotetan approved by the US FDA?

Drugs@FDA lists 9 application product lines for Cefotetan, including CEFOTAN (Prescription); CEFOTETAN (Prescription); CEFOTAN (Discontinued); CEFOTAN (Discontinued); CEFOTAN IN PLASTIC CONTAINER (Discontinued).

Are there safety signals or safety updates for Cefotetan?

US FDA: 2 entries (latest 2020-01-30).

Active substance

Cefotetan

US FDA 9
Safety 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
CEFOTAN	EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL	injectable · injection	PAI HOLDINGS PHARM	Prescription	27 Dec 1985
CEFOTETAN	EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL	injectable · injection	FRESENIUS KABI USA	Prescription	9 Aug 2007
CEFOTAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	PAI HOLDINGS PHARM	Discontinued	27 Dec 1985
CEFOTAN	EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL	injectable · injection	TELIGENT	Discontinued	29 Apr 1993
CEFOTAN IN PLASTIC CONTAINER	EQ 40MG BASE/ML; EQ 20MG BASE/ML	injectable · injection	PAI HOLDINGS PHARM	Discontinued	30 Jul 1993
CEFOTETAN	EQ 10GM BASE/VIAL	injectable · injection	FRESENIUS KABI USA	Discontinued	9 Aug 2007
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL	injectable · injection	B BRAUN	Discontinued	9 Aug 2007
CEFOTETAN	EQ 10GM BASE/VIAL	injectable · injection	WEST-WARD PHARM CORP	Discontinued	26 Oct 2011
CEFOTETAN	EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL	injectable · injection	HIKMA	Discontinued	26 Oct 2011

Safety signals and safety-related labeling changes

US FDA 30 Jan 2020 CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER — safety-related labeling change
Labeling sections changed: Use in Specific Populations
US FDA 9 Mar 2017 CEFOTAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations

All safety entries for cefotetan →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.