Nitrolingual, Nitrolingual Pumpspray

Relieves an attack or prophylaxis of angina pectoris due to coronary artery disease. NDA 18705, held by Pohl Boskamp. Nitroglycerin.

As of Nov 13, 2026, NDA 18705 (Nitrolingual, Nitrolingual Pumpspray), held by Pohl Boskamp, was first approved by FDA on Oct 31, 1985, with 19 approved supplements and 0 published complete response letters.

First approved: Oct 31, 1985
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Jan 10, 1997	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 31, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Nitrolingual0.4MG/SPRAY · aerosol;sublingual	Nitroglycerin	Discontinued
Nitrolingual Pumpspray0.4MG/SPRAY · spray, metered;sublingual	Nitroglycerin	RxReference drug

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 30, 2018	Supplement 25Labeling · Standard review	Approved	Label Letter
Sep 2, 2016	Supplement 21Labeling · Standard review	Approved	None posted
Apr 21, 2016	Supplement 20Manufacturing · Standard review	Approved	None posted
Jan 23, 2015	Supplement 19Labeling · Standard review	Approved	Label Letter
Oct 1, 2008	Supplement 17Manufacturing	Approved	Label Letter
Sep 28, 2006	Supplement 16Labeling · Standard review	Approved	Letter
Feb 13, 2006	Supplement 15Labeling · Standard review	Approved	Letter
Sep 2, 2004	Supplement 13Labeling · Standard review	Approved	Letter
Nov 5, 2002	Supplement 12Manufacturing · Standard review	Approved	Letter
Nov 4, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 4, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 13, 1999	Supplement 8Labeling · Standard review	Approved	None posted
Apr 24, 1998	Supplement 7Labeling · Standard review	Approved	None posted
Jan 10, 1997	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Jan 11, 1995	Supplement 5Labeling · Standard review	Approved	None posted
Mar 2, 1990	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 13, 1989	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 2, 1988	Supplement 2Labeling	Approved	None posted
Apr 23, 1986	Supplement 1Labeling	Approved	None posted
Oct 31, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18705
Drugs@FDA: Overview at FDA
Company: Pohl-Boskamp

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