Cefmax

NDA 50571, held by Tap Pharm. Cefmenoxime Hydrochloride.

As of Nov 13, 2026, NDA 50571 (Cefmax), held by Tap Pharm, was first approved by FDA on Dec 30, 1987, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 30, 1987
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 30, 1987	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
CefmaxEQ 500MG BASE/VIAL · injectable;injection	Cefmenoxime Hydrochloride	Discontinued
CefmaxEQ 1GM BASE/VIAL · injectable;injection	Cefmenoxime Hydrochloride	Discontinued
CefmaxEQ 2GM BASE/VIAL · injectable;injection	Cefmenoxime Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 6, 1988	Supplement 1Labeling · Standard review	Approved	None posted
Dec 30, 1987	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 50571
Drugs@FDA: Overview at FDA
Company: TAP Pharmaceuticals

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