Nitro-Bid

NDA 18621, held by Sanofi Aventis US. Nitroglycerin.

As of Nov 14, 2026, NDA 18621 (Nitro-Bid), held by Sanofi Aventis US, was first approved by FDA on Jan 5, 1982, with 14 approved supplements and 0 published complete response letters.

First approved: Jan 5, 1982
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
Jan 5, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nitro-Bid5MG/ML · injectable;injection	Nitroglycerin	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Dec 15, 1997	Supplement 20Manufacturing	Approved	None posted
Sep 29, 1997	Supplement 21Labeling	Approved	None posted
Nov 29, 1996	Supplement 19Labeling	Approved	None posted
Jul 11, 1996	Supplement 18Labeling	Approved	None posted
Jun 22, 1995	Supplement 17Manufacturing	Approved	None posted
Nov 30, 1994	Supplement 16Manufacturing	Approved	None posted
Jun 21, 1993	Supplement 14Labeling	Approved	None posted
Nov 18, 1992	Supplement 13Labeling	Approved	None posted
Sep 21, 1989	Supplement 8Manufacturing	Approved	None posted
Sep 21, 1989	Supplement 9Manufacturing	Approved	None posted
Sep 21, 1989	Supplement 10Labeling	Approved	None posted
Sep 21, 1989	Supplement 11Manufacturing	Approved	None posted
Dec 16, 1987	Supplement 7Manufacturing	Approved	None posted
Jun 14, 1985	Supplement 6Manufacturing	Approved	None posted
Jan 5, 1982	Original application	Approved	None posted

Identifiers

Application: NDA 18621
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