Inderide-40/25, Inderide-80/25

NDA 18031, held by Wyeth Pharms Inc. Hydrochlorothiazide; Propranolol Hydrochloride.

As of Nov 13, 2026, NDA 18031 (Inderide-40/25, Inderide-80/25), held by Wyeth Pharms Inc, was first approved by FDA on Jun 15, 1979, with 35 approved supplements and 0 published complete response letters.

First approved: Jun 15, 1979
Review: Standard
Supplements approved: 35
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below


Feb 8, 1990	Supplement 18Efficacy (new indication or use)	Approved	None posted
Jun 15, 1979	Original applicationNew combination · Standard review	Approved	None posted

Products

2 strengths and forms


Inderide-40/2525MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Hydrochlorothiazide; Propranolol Hydrochloride	DiscontinuedReference drug
Inderide-80/2525MG;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Hydrochlorothiazide; Propranolol Hydrochloride	DiscontinuedReference drug

All 36 submissions, including labeling and manufacturing supplements


Mar 17, 2011	Supplement 38Labeling	Approved	Letter Label
Mar 17, 2011	Supplement 37Labeling	Approved	Letter Label
Mar 4, 2010	Supplement 36Labeling	Approved	Letter Label
Jan 2, 2008	Supplement 35Labeling · Standard review	Approved	Letter Label
Feb 21, 2007	Supplement 34Labeling · Standard review	Approved	Letter
Dec 29, 2006	Supplement 33Labeling · Standard review	Approved	Letter
Jun 9, 2004	Supplement 32Labeling · Standard review	Approved	Letter
Nov 1, 2001	Supplement 30Labeling · Standard review	Approved	None posted
May 3, 2001	Supplement 31Labeling · Standard review	Approved	None posted
Nov 7, 1997	Supplement 29Labeling · Standard review	Approved	None posted
Jun 14, 1994	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 8, 1990	Supplement 18Efficacy (new indication or use)	Approved	None posted
Feb 8, 1990	Supplement 17Labeling	Approved	None posted
Aug 9, 1989	Supplement 27Manufacturing · Standard review	Approved	None posted
Jul 10, 1989	Supplement 25Manufacturing · Standard review	Approved	None posted
Apr 12, 1989	Supplement 26Manufacturing · Standard review	Approved	None posted
Nov 7, 1988	Supplement 24Labeling	Approved	None posted
May 25, 1988	Supplement 23Manufacturing · Standard review	Approved	None posted
Dec 30, 1986	Supplement 22Manufacturing · Standard review	Approved	None posted
Jul 24, 1986	Supplement 19Manufacturing · Standard review	Approved	None posted
Feb 22, 1985	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 11, 1983	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 23, 1982	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 9, 1982	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 28, 1982	Supplement 11Labeling	Approved	None posted
Apr 12, 1982	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 3, 1982	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 26, 1982	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 10, 1981	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 27, 1981	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 3, 1980	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 19, 1980	Supplement 8Manufacturing · Standard review	Approved	None posted
May 28, 1980	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 27, 1980	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 31, 1979	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 15, 1979	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 18031
Drugs@FDA: Overview at FDA
Company: Wyeth 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