Univasc

NDA 20312, held by Ucb Inc. Moexipril Hydrochloride.

As of Nov 14, 2026, NDA 20312 (Univasc), held by Ucb Inc, was first approved by FDA on Apr 19, 1995, with 23 approved supplements and 0 published complete response letters.

First approved: Apr 19, 1995
Review: Standard
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Apr 19, 1995	Original applicationNew molecular entity · Standard review	Approved	Review Review

Products

2 strengths and forms


Univasc7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Moexipril Hydrochloride	Discontinued
Univasc15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Moexipril Hydrochloride	Discontinued

All 24 submissions, including labeling and manufacturing supplements


Sep 14, 2012	Supplement 35Labeling	Approved	Label Letter
Jan 19, 2012	Supplement 34Labeling	Approved	Letter Label
Aug 23, 2011	Supplement 33Labeling	Approved	Label Letter
Jan 13, 2010	Supplement 31Labeling	Approved	Label Letter
Oct 29, 2003	Supplement 24Labeling · Standard review	Approved	Letter
Dec 9, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
Oct 2, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 24, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 11, 2001	Supplement 16Labeling · Standard review	Approved	Letter
Mar 28, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 18, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 2, 2000	Supplement 14Labeling · Standard review	Approved	None posted
Oct 29, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 11, 1999	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 3, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 8, 1998	Supplement 10Labeling · Standard review	Approved	None posted
Nov 8, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 3, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 9, 1996	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 17, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 18, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 18, 1995	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 18, 1995	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 19, 1995	Original applicationNew molecular entity · Standard review	Approved	Review Review

Identifiers

Application: NDA 20312
Drugs@FDA: Overview at FDA
Company: UCB

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