Primacor

NDA 19436, held by Sanofi Aventis US. Milrinone Lactate.

As of Nov 13, 2026, NDA 19436 (Primacor), held by Sanofi Aventis US, was first approved by FDA on Dec 31, 1987, with 18 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1987
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Dec 31, 1987	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
PrimacorEQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Milrinone Lactate	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements


Oct 30, 2007	Supplement 22Labeling · Standard review	Approved	Label Letter
May 1, 2007	Supplement 21Labeling · Standard review	Approved	Label Letter
Apr 18, 2003	Supplement 19Labeling · Standard review	Approved	Letter
Oct 30, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 16, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Oct 18, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 6, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 29, 2000	Supplement 13Labeling · Standard review	Approved	None posted
Jul 6, 1999	Supplement 12Labeling · Standard review	Approved	None posted
Mar 16, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 15, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 6, 1995	Supplement 7Labeling · Standard review	Approved	None posted
Sep 6, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 7, 1995	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 1, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 20, 1992	Supplement 3Labeling · Standard review	Approved	None posted
Jul 9, 1991	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 14, 1989	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 31, 1987	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19436
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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