Cefobid In Plastic Container

NDA 50613, held by Pfizer. Cefoperazone Sodium.

As of Nov 13, 2026, NDA 50613 (Cefobid In Plastic Container), held by Pfizer, was first approved by FDA on Jul 23, 1986, with 8 approved supplements and 0 published complete response letters.

First approved: Jul 23, 1986
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jul 23, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Cefobid In Plastic ContainerEQ 40MG BASE/ML · injectable;injection	Cefoperazone Sodium	Discontinued
Cefobid In Plastic ContainerEQ 20MG BASE/ML · injectable;injection	Cefoperazone Sodium	Discontinued

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 1, 1998	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 3, 1996	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 28, 1994	Supplement 7Labeling · Standard review	Approved	None posted
Aug 1, 1989	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 29, 1988	Supplement 1Labeling	Approved	None posted
Jul 20, 1988	Supplement 2Labeling	Approved	None posted
Nov 10, 1987	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 31, 1987	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 23, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50613
Drugs@FDA: Overview at FDA
Company: Pfizer

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