Transderm-Nitro

NDA 20144, held by Novartis. Nitroglycerin.

As of Nov 14, 2026, NDA 20144 (Transderm-Nitro), held by Novartis, was first approved by FDA on Oct 19, 1981, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 19, 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 19, 1981	Original application	Approved	None posted

Products

5 strengths and forms


Transderm-Nitro0.1MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · film, extended release;transdermal	Nitroglycerin	DiscontinuedReference drug
Transderm-Nitro0.2MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · film, extended release;transdermal	Nitroglycerin	DiscontinuedReference drug
Transderm-Nitro0.4MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · film, extended release;transdermal	Nitroglycerin	DiscontinuedReference drug
Transderm-Nitro0.6MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · film, extended release;transdermal	Nitroglycerin	DiscontinuedReference drug
Transderm-Nitro0.8MG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · film, extended release;transdermal	Nitroglycerin	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Sep 20, 2000	Supplement 19Labeling · Standard review	Approved	None posted
Feb 3, 1999	Supplement 18Labeling · Standard review	Approved	None posted
Oct 15, 1998	Supplement 17Manufacturing	Approved	None posted
Oct 23, 1997	Supplement 16Manufacturing	Approved	None posted
Dec 10, 1996	Supplement 14Manufacturing	Approved	None posted
Feb 27, 1996	Supplement 2Manufacturing	Approved	None posted
Feb 27, 1996	Supplement 3Manufacturing	Approved	None posted
Feb 27, 1996	Supplement 5Manufacturing	Approved	None posted
Feb 27, 1996	Supplement 7Manufacturing	Approved	None posted
Feb 27, 1996	Supplement 8Manufacturing	Approved	None posted
Oct 19, 1981	Original application	Approved	None posted

Identifiers

Application: NDA 20144
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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