Tridil

NDA 18537, held by Hospira. Nitroglycerin.

As of Nov 13, 2026, NDA 18537 (Tridil), held by Hospira, was first approved by FDA on Sep 30, 1981, with 14 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1981
Review: Priority
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
Sep 30, 1981	Original applicationNew dosage form · Priority review	Approved	None posted

Products

2 strengths and forms


Tridil5MG/ML · injectable;injection	Nitroglycerin	Discontinued
Tridil0.5MG/ML · injectable;injection	Nitroglycerin	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Nov 5, 2001	Supplement 16Manufacturing · Priority review	Approved	None posted
Dec 9, 1998	Supplement 15Labeling · Standard review	Approved	None posted
Dec 15, 1995	Supplement 13Labeling · Standard review	Approved	None posted
Feb 22, 1995	Supplement 12Labeling · Standard review	Approved	None posted
Jul 25, 1994	Supplement 11Labeling · Standard review	Approved	None posted
Jul 3, 1991	Supplement 10Labeling	Approved	None posted
Nov 17, 1986	Supplement 9Manufacturing · Priority review	Approved	None posted
Aug 22, 1984	Supplement 8Labeling	Approved	None posted
Aug 22, 1984	Supplement 7Manufacturing · Priority review	Approved	None posted
Jan 12, 1984	Supplement 4Labeling	Approved	None posted
Jul 8, 1983	Supplement 5Manufacturing · Priority review	Approved	None posted
Jun 24, 1983	Supplement 3Manufacturing · Priority review	Approved	None posted
Jun 16, 1983	Supplement 2Manufacturing · Priority review	Approved	None posted
Mar 9, 1982	Supplement 1Manufacturing · Priority review	Approved	None posted
Sep 30, 1981	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 18537
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