Monopril

NDA 19915, held by Bristol Myers Squibb. Fosinopril Sodium.

As of Nov 13, 2026, NDA 19915 (Monopril), held by Bristol Myers Squibb, was first approved by FDA on May 16, 1991, with 37 approved supplements and 0 published complete response letters.

First approved: May 16, 1991
Review: Standard
Supplements approved: 37
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 38 submissions below


May 27, 2003	Supplement 37Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Written Request
May 2, 1995	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
May 16, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms


Monopril10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Fosinopril Sodium	DiscontinuedReference drug
Monopril20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Fosinopril Sodium	DiscontinuedReference drug
Monopril40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Fosinopril Sodium	DiscontinuedReference drug

All 38 submissions, including labeling and manufacturing supplements


Feb 9, 2009	Supplement 42Labeling · Standard review	Approved	Letter
Oct 29, 2003	Supplement 38Labeling · Standard review	Approved	Letter
May 27, 2003	Supplement 37Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Written Request
Aug 29, 2002	Supplement 32Labeling · Standard review	Approved	Review Letter
Sep 21, 2000	Supplement 34Manufacturing · Standard review	Approved	None posted
Jun 26, 2000	Supplement 33Manufacturing · Standard review	Approved	None posted
Nov 16, 1999	Supplement 31Manufacturing · Standard review	Approved	None posted
May 24, 1999	Supplement 30Manufacturing · Standard review	Approved	None posted
May 21, 1999	Supplement 29Manufacturing · Standard review	Approved	None posted
Mar 11, 1999	Supplement 28Manufacturing · Standard review	Approved	None posted
Aug 11, 1998	Supplement 27Manufacturing · Standard review	Approved	None posted
Jan 28, 1998	Supplement 26Manufacturing · Standard review	Approved	None posted
Oct 1, 1997	Supplement 25Manufacturing · Standard review	Approved	None posted
Sep 12, 1997	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 21, 1997	Supplement 23Manufacturing · Standard review	Approved	None posted
Jan 14, 1997	Supplement 22Manufacturing · Standard review	Approved	None posted
Jan 8, 1997	Supplement 21Labeling · Standard review	Approved	None posted
Aug 2, 1996	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 24, 1996	Supplement 17Labeling · Standard review	Approved	None posted
Mar 20, 1996	Supplement 19Manufacturing · Standard review	Approved	None posted
Sep 29, 1995	Supplement 18Manufacturing · Standard review	Approved	None posted
May 2, 1995	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 28, 1995	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 27, 1995	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 8, 1995	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 30, 1994	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 30, 1994	Supplement 12Manufacturing · Standard review	Approved	None posted
Jun 14, 1994	Supplement 11Manufacturing · Standard review	Approved	None posted
May 19, 1994	Supplement 10Labeling · Standard review	Approved	None posted
Apr 5, 1993	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 7, 1992	Supplement 7Labeling · Standard review	Approved	None posted
Sep 22, 1992	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 10, 1992	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 25, 1992	Supplement 4Labeling · Standard review	Approved	None posted
Sep 9, 1991	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 27, 1991	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 27, 1991	Supplement 1Manufacturing · Standard review	Approved	None posted
May 16, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19915
Drugs@FDA: Overview at FDA
Company: Bristol-Myers Squibb

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