Nitroglycerin

NDA 18531, held by Hospira. Nitroglycerin.

As of Nov 13, 2026, NDA 18531 (Nitroglycerin), held by Hospira, was first approved by FDA on Oct 6, 1981, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 6, 1981
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Oct 6, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nitroglycerin5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Nitroglycerin	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Aug 30, 1999	Supplement 13Labeling	Approved	None posted
Feb 12, 1998	Supplement 12Labeling	Approved	None posted
Aug 14, 1996	Supplement 11Labeling	Approved	None posted
Jun 14, 1996	Supplement 10Labeling	Approved	None posted
Jul 8, 1994	Supplement 9Labeling	Approved	None posted
Dec 1, 1993	Supplement 8Labeling	Approved	None posted
Aug 5, 1993	Supplement 7Labeling	Approved	None posted
May 3, 1990	Supplement 5Labeling	Approved	None posted
Aug 24, 1989	Supplement 6Labeling	Approved	None posted
Apr 27, 1987	Supplement 4Manufacturing	Approved	None posted
Oct 6, 1981	Original application	Approved	None posted

Identifiers

Application: NDA 18531
Drugs@FDA: Overview at FDA
Company: Hospira

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