Primacor In Dextrose 5% In Plastic Container

NDA 20343, held by Sanofi Aventis US. Milrinone Lactate.

As of Nov 14, 2026, NDA 20343 (Primacor In Dextrose 5% In Plastic Container), held by Sanofi Aventis US, was first approved by FDA on Aug 9, 1994, with 14 approved supplements and 0 published complete response letters.

First approved: Aug 9, 1994
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Aug 9, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Products

4 strengths and forms


Primacor In Dextrose 5% In Plastic ContainerEQ 10MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Milrinone Lactate	DiscontinuedReference drug
Primacor In Dextrose 5% In Plastic ContainerEQ 15MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Milrinone Lactate	DiscontinuedReference drug
Primacor In Dextrose 5% In Plastic ContainerEQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Milrinone Lactate	DiscontinuedReference drug
Primacor In Dextrose 5% In Plastic ContainerEQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Milrinone Lactate	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Oct 30, 2007	Supplement 21Labeling · Standard review	Approved	Letter
May 1, 2007	Supplement 20Labeling · Standard review	Approved	Letter
Apr 9, 2003	Supplement 14Labeling · Standard review	Approved	Letter
Sep 16, 2002	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 18, 2001	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 29, 2000	Supplement 10Labeling · Standard review	Approved	None posted
May 10, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 6, 1999	Supplement 8Labeling · Standard review	Approved	None posted
Oct 8, 1998	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 25, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 15, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 13, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 24, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 4, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 9, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20343
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