Cefotetan And Dextrose In Duplex Container

NDA 65430, held by B Braun. Cefotetan Disodium.

As of Nov 13, 2026, NDA 65430 (Cefotetan And Dextrose In Duplex Container), held by B Braun, was first approved by FDA on Aug 9, 2007, with 2 approved supplements and 0 published complete response letters.

First approved: Aug 9, 2007
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Aug 9, 2007	Original application	Approved	Letter

Products

2 strengths and forms


Cefotetan And Dextrose In Duplex ContainerEQ 1GM BASE/VIAL · injectable;injection	Cefotetan Disodium	DiscontinuedReference drug
Cefotetan And Dextrose In Duplex ContainerEQ 2GM BASE/VIAL · injectable;injection	Cefotetan Disodium	DiscontinuedReference drug

All 3 submissions, including labeling and manufacturing supplements


Jan 30, 2020	Supplement 9Labeling · Standard review	Approved	Label Letter
Dec 18, 2013	Supplement 6Manufacturing	Approved	None posted
Aug 9, 2007	Original application	Approved	Letter

Identifiers

Application: NDA 65430
Drugs@FDA: Overview at FDA
Company: B. Braun Medical

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters