Vasotec

NDA 19309, held by Biovail Labs Intl. Enalaprilat.

As of Nov 13, 2026, NDA 19309 (Vasotec), held by Biovail Labs Intl, was first approved by FDA on Feb 9, 1988, with 26 approved supplements and 0 published complete response letters.

First approved: Feb 9, 1988
Review: Standard
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Feb 9, 1988	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vasotec1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Enalaprilat	DiscontinuedReference drug

All 27 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 25, 2002	Supplement 27Manufacturing · Standard review	Approved	None posted
Nov 1, 2002	Supplement 25Labeling · Standard review	Approved	Letter
Dec 17, 2001	Supplement 26Manufacturing · Standard review	Approved	None posted
Nov 27, 2001	Supplement 23Labeling · Standard review	Approved	Letter Review
Dec 6, 2000	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 17, 1999	Supplement 22Labeling · Standard review	Approved	Review
Oct 27, 1997	Supplement 20Labeling · Standard review	Approved	None posted
Jun 11, 1997	Supplement 21Labeling · Standard review	Approved	Review
Jul 31, 1996	Supplement 12Labeling · Standard review	Approved	Review
Sep 28, 1995	Supplement 19Labeling · Standard review	Approved	Review
Jul 25, 1994	Supplement 18Labeling · Standard review	Approved	Review
May 11, 1994	Supplement 15Labeling · Standard review	Approved	Review
Feb 18, 1994	Supplement 17Labeling · Standard review	Approved	Review
Jan 14, 1994	Supplement 14Labeling · Standard review	Approved	Review
Oct 21, 1993	Supplement 16Labeling · Standard review	Approved	Review
Feb 24, 1993	Supplement 13Labeling · Standard review	Approved	Review
Sep 30, 1992	Supplement 11Labeling · Standard review	Approved	Review
May 13, 1992	Supplement 10Labeling · Standard review	Approved	None posted
May 7, 1992	Supplement 9Labeling · Standard review	Approved	None posted
Jan 29, 1992	Supplement 7Labeling · Standard review	Approved	None posted
Feb 6, 1991	Supplement 8Labeling · Standard review	Approved	Review
Mar 9, 1990	Supplement 6Labeling · Standard review	Approved	None posted
Nov 30, 1989	Supplement 5Labeling · Standard review	Approved	Review
Oct 19, 1989	Supplement 4Labeling · Standard review	Approved	None posted
Apr 18, 1989	Supplement 3Labeling · Standard review	Approved	None posted
Jan 10, 1989	Supplement 1Labeling · Standard review	Approved	None posted
Feb 9, 1988	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 19309
Drugs@FDA: Overview at FDA
Company: Biovail Laboratories International

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