Nitro-Dur

Prevents angina pectoris due to coronary artery disease. NDA 20145, held by Uspharma. Nitroglycerin.

As of Nov 14, 2026, NDA 20145 (Nitro-Dur), held by Uspharma, was first approved by FDA on Dec 10, 1985, with 16 approved supplements and 0 published complete response letters.

First approved: Dec 10, 1985
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute attack.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Dec 10, 1985	Original application	Approved	None posted

Products

6 strengths and forms


Nitro-Dur0.1MG/HR · film, extended release;transdermal	Nitroglycerin	RxReference drug
Nitro-Dur0.2MG/HR · film, extended release;transdermal	Nitroglycerin	RxReference drug
Nitro-Dur0.3MG/HR · film, extended release;transdermal	Nitroglycerin	RxReference drug
Nitro-Dur0.4MG/HR · film, extended release;transdermal	Nitroglycerin	RxReference drug
Nitro-Dur0.6MG/HR · film, extended release;transdermal	Nitroglycerin	RxReference drug
Nitro-Dur0.8MG/HR · film, extended release;transdermal	Nitroglycerin	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Jan 8, 2016	Supplement 28Manufacturing	Approved	None posted
Oct 2, 2014	Supplement 27Labeling · Standard review	Approved	Letter Label
Apr 5, 2005	Supplement 21Labeling · Standard review	Approved	Letter
Jun 24, 2004	Supplement 15Labeling · Standard review	Approved	Letter
Oct 18, 2002	Supplement 16Manufacturing	Approved	Letter
Mar 7, 2002	Supplement 14Manufacturing	Approved	None posted
May 31, 2001	Supplement 13Manufacturing	Approved	None posted
Aug 23, 2000	Supplement 12Manufacturing	Approved	None posted
Feb 17, 1999	Supplement 11Labeling · Standard review	Approved	None posted
Jun 4, 1997	Supplement 10Manufacturing	Approved	None posted
Feb 7, 1996	Supplement 9Labeling · Standard review	Approved	None posted
Nov 8, 1995	Supplement 8Manufacturing	Approved	None posted
May 23, 1995	Supplement 7Labeling · Standard review	Approved	Review
Apr 14, 1995	Supplement 6Labeling · Standard review	Approved	Review
Apr 4, 1995	Supplement 4Manufacturing	Approved	None posted
Apr 4, 1995	Supplement 1Manufacturing	Approved	None posted
Dec 10, 1985	Original application	Approved	None posted

Identifiers

Application: NDA 20145
Drugs@FDA: Overview at FDA
Company: USpharma

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