Primaxin

NDA 50630, held by Merck. Cilastatin Sodium; Imipenem.

As of Nov 13, 2026, NDA 50630 (Primaxin), held by Merck, was first approved by FDA on Dec 14, 1990, with 23 approved supplements and 0 published complete response letters.

First approved: Dec 14, 1990
Review: Standard
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Dec 14, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


PrimaxinEQ 500MG BASE/VIAL;500MG/VIAL · powder;intramuscular	Cilastatin Sodium; Imipenem	Discontinued
PrimaxinEQ 750MG BASE/VIAL;750MG/VIAL · powder;intramuscular	Cilastatin Sodium; Imipenem	Discontinued

All 24 submissions, including labeling and manufacturing supplements


Aug 26, 2009	Supplement 35Labeling	Approved	Letter Label
May 8, 2008	Supplement 33Labeling · Standard review	Approved	Letter
Mar 28, 2008	Supplement 28Labeling · Standard review	Approved	Letter Label
Mar 22, 2007	Supplement 27Labeling · Standard review	Approved	Label Letter
Aug 4, 2006	Supplement 26Labeling · Standard review	Approved	Letter
May 20, 2004	Supplement 23Labeling · Standard review	Approved	Review Letter
Mar 4, 2003	Supplement 21Labeling · Standard review	Approved	Review Letter
May 28, 2002	Supplement 19Manufacturing · Standard review	Approved	Review
Nov 30, 2001	Supplement 17Labeling · Standard review	Approved	Letter
Aug 29, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 10, 2000	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 4, 1999	Supplement 15Labeling · Standard review	Approved	Review
Jun 30, 1997	Supplement 14Labeling · Standard review	Approved	Review
Jan 9, 1997	Supplement 11Labeling · Standard review	Approved	Review
Oct 2, 1996	Supplement 9Labeling · Standard review	Approved	Review
Apr 27, 1995	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 27, 1994	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 24, 1994	Supplement 8Labeling	Approved	None posted
Nov 4, 1993	Supplement 5Labeling	Approved	None posted
Nov 4, 1993	Supplement 2Labeling	Approved	None posted
Nov 23, 1992	Supplement 7Labeling	Approved	None posted
Nov 23, 1992	Supplement 6Labeling	Approved	None posted
Aug 26, 1991	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 14, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50630
Drugs@FDA: Overview at FDA
Company: Merck & Co. (MSD)

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