Cefpiramide Sodium

NDA 50633, held by Wyeth Ayerst. Cefpiramide Sodium.

As of Nov 13, 2026, NDA 50633 (Cefpiramide Sodium), held by Wyeth Ayerst, was first approved by FDA on Jan 31, 1989, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 31, 1989
Review: Standard
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
Jan 31, 1989	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms


Cefpiramide SodiumEQ 1GM BASE/VIAL · injectable;injection	Cefpiramide Sodium	Discontinued
Cefpiramide SodiumEQ 2GM BASE/VIAL · injectable;injection	Cefpiramide Sodium	Discontinued
Cefpiramide SodiumEQ 10GM BASE/VIAL · injectable;injection	Cefpiramide Sodium	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Aug 21, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
May 10, 1989	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 31, 1989	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 50633
Drugs@FDA: Overview at FDA
Company: Wyeth-Ayerst

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