Lopressor Hct

NDA 18303, held by Validus Pharms. Hydrochlorothiazide; Metoprolol Tartrate.

As of Nov 13, 2026, NDA 18303 (Lopressor Hct), held by Validus Pharms, was first approved by FDA on Dec 31, 1984, with 33 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1984
Review: Standard
Supplements approved: 33
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 34 submissions below

Date	Submission	Status	Documents
Dec 31, 1984	Original applicationNew combination · Standard review	Approved	None posted

Products

3 strengths and forms


Lopressor Hct25MG;50MG · tablet;oral	Hydrochlorothiazide; Metoprolol Tartrate	RxReference drug
Lopressor Hct25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Hydrochlorothiazide; Metoprolol Tartrate	DiscontinuedReference drug
Lopressor Hct50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Hydrochlorothiazide; Metoprolol Tartrate	DiscontinuedReference drug

All 34 submissions, including labeling and manufacturing supplements


Dec 22, 2023	Supplement 42Labeling · Standard review	Approved	Letter Label
May 3, 2022	Supplement 40Labeling · Standard review	Approved	Label Letter
Aug 20, 2020	Supplement 41Labeling · Standard review	Approved	Letter Label
Mar 15, 2011	Supplement 36Labeling	Approved	Label
Mar 15, 2011	Supplement 35Labeling	Approved	Label
Aug 7, 2009	Supplement 34Labeling · Standard review	Approved	Letter Label
Jul 24, 2008	Supplement 33Labeling · Standard review	Approved	Letter Label
Jan 8, 2008	Supplement 32Labeling · Standard review	Approved	Letter Label
Sep 7, 2006	Supplement 29Labeling · Standard review	Approved	Letter
Oct 31, 2003	Supplement 25Labeling · Standard review	Approved	Letter
Jun 14, 2002	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 29, 2002	Supplement 23Manufacturing · Standard review	Approved	None posted
Feb 8, 2002	Supplement 22Manufacturing · Standard review	Approved	None posted
Jul 30, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
May 12, 2000	Supplement 19Manufacturing · Standard review	Approved	None posted
May 10, 2000	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 28, 1999	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 18, 1999	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 7, 1997	Supplement 16Labeling · Standard review	Approved	None posted
Jan 8, 1997	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 7, 1996	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 4, 1996	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 31, 1995	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 2, 1995	Supplement 11Labeling · Standard review	Approved	None posted
Nov 8, 1991	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 18, 1991	Supplement 9Labeling	Approved	None posted
Jun 14, 1990	Supplement 8Labeling	Approved	None posted
Dec 9, 1988	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 23, 1988	Supplement 5Labeling	Approved	None posted
May 31, 1988	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 23, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 26, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 22, 1985	Supplement 2Labeling	Approved	None posted
Dec 31, 1984	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 18303
Drugs@FDA: Overview at FDA
Company: Validus Pharmaceuticals

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