Monoket

Treats angina pectoris due to coronary artery disease. NDA 20215, held by Omnivium Pharms. Isosorbide Mononitrate.

As of Nov 15, 2026, NDA 20215 (Monoket), held by Omnivium Pharms, was first approved by FDA on Jun 30, 1993, with 14 approved supplements and 0 published complete response letters.

First approved: Jun 30, 1993
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: Isosorbide Mononitrate Tablets are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jun 30, 1993	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Monoket20MG · tablet;oral	Isosorbide Mononitrate	RxReference drug
Monoket10MG · tablet;oral	Isosorbide Mononitrate	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Feb 1, 2022	Supplement 27Manufacturing	Approved	Letter
Oct 2, 2014	Supplement 24Labeling · Standard review	Approved	Letter Label
May 15, 2002	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 22, 2000	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 19, 2000	Supplement 11Labeling · Standard review	Approved	None posted
Oct 29, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 26, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 13, 1999	Supplement 8Labeling · Standard review	Approved	None posted
Aug 25, 1997	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 7, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 12, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 20, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 2, 1994	Supplement 2Labeling · Standard review	Approved	None posted
Dec 15, 1993	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 30, 1993	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20215
Drugs@FDA: Overview at FDA
Company: Omnivium Pharmaceuticals

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