Uniretic

NDA 20729, held by Ucb Inc. Hydrochlorothiazide; Moexipril Hydrochloride.

As of Nov 13, 2026, NDA 20729 (Uniretic), held by Ucb Inc, was first approved by FDA on Jun 27, 1997, with 16 approved supplements and 0 published complete response letters.

First approved: Jun 27, 1997
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jun 27, 1997	Original applicationNew combination · Standard review	Approved	None posted

Products

3 strengths and forms


Uniretic12.5MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Hydrochlorothiazide; Moexipril Hydrochloride	Discontinued
Uniretic25MG;15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Hydrochlorothiazide; Moexipril Hydrochloride	Discontinued
Uniretic12.5MG;15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Hydrochlorothiazide; Moexipril Hydrochloride	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Sep 13, 2012	Supplement 26Labeling	Approved	Letter Label
Jan 19, 2012	Supplement 25Labeling	Approved	Letter Label
Aug 23, 2011	Supplement 24Labeling	Approved	Label Letter
May 19, 2011	Supplement 23Labeling	Approved	Label
Jan 13, 2010	Supplement 21Labeling	Approved	Label Letter
Oct 29, 2003	Supplement 12Labeling · Standard review	Approved	Letter
Feb 14, 2002	Supplement 10Manufacturing · Standard review	Approved	Review Letter
Sep 24, 2001	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 12, 2001	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 22, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
May 10, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 5, 2000	Supplement 5Labeling · Standard review	Approved	None posted
Oct 29, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 22, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 21, 1998	Supplement 2Labeling · Standard review	Approved	None posted
Nov 18, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 27, 1997	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 20729
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