Ismo

NDA 19091, held by Promius Pharma. Isosorbide Mononitrate.

As of Nov 13, 2026, NDA 19091 (Ismo), held by Promius Pharma, was first approved by FDA on Dec 30, 1991, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1991
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Dec 30, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ismo20MG · tablet;oral	Isosorbide Mononitrate	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 13, 2000	Supplement 8Labeling · Standard review	Approved	None posted
Jun 16, 1999	Supplement 7Labeling · Standard review	Approved	None posted
Jan 13, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 10, 1997	Supplement 5Labeling · Standard review	Approved	None posted
Apr 8, 1994	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 20, 1993	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 26, 1993	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 30, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19091
Drugs@FDA: Overview at FDA
Company: Promius Pharma

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