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Altace

NDA 19901, held by King Pharms LLC. Ramipril.

As of Nov 13, 2026, NDA 19901 (Altace), held by King Pharms LLC, was first approved by FDA on Jan 28, 1991, with 51 approved supplements and 0 published complete response letters.

First approved: Jan 28, 1991
Review: Standard
Supplements approved: 51
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 52 submissions below

Date	Submission	Status	Documents
Oct 4, 2000	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Review
Aug 22, 1995	Supplement 10Efficacy (new indication or use) · Standard review	Approved	None posted
Jan 28, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Altace1.25MG · capsule;oral	Ramipril	DiscontinuedReference drug
Altace2.5MG · capsule;oral	Ramipril	DiscontinuedReference drug
Altace5MG · capsule;oral	Ramipril	DiscontinuedReference drug
Altace10MG · capsule;oral	Ramipril	DiscontinuedReference drug

All 52 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 7, 2026	Supplement 72Labeling · Standard review	Approved	Label Letter
Apr 26, 2017	Supplement 67Labeling · Standard review	Approved	Letter Label
Sep 11, 2015	Supplement 65Labeling · Standard review	Approved	Letter Label
May 2, 2014	Supplement 64Labeling · Standard review	Approved	Letter Label
Nov 4, 2013	Supplement 62Labeling · Standard review	Approved	Letter Label
Oct 25, 2013	Supplement 63Labeling · Standard review	Approved	Label Letter
Sep 23, 2013	Supplement 60Labeling · Standard review	Approved	Letter Label
Apr 11, 2012	Supplement 59Labeling	Approved	Label Letter
Aug 23, 2011	Supplement 58Labeling	Approved	Label Letter
Oct 21, 2010	Supplement 55Labeling · Standard review	Approved	Label Letter
Mar 4, 2009	Supplement 52Labeling · Standard review	Approved	Letter
Feb 9, 2009	Supplement 54Labeling · Standard review	Approved	Letter
Nov 15, 2004	Supplement 46Labeling · Standard review	Approved	Review Letter
Oct 15, 2004	Supplement 43Labeling · Standard review	Approved	Letter
Oct 15, 2004	Supplement 41Labeling · Standard review	Approved	Letter
Oct 15, 2004	Supplement 40Labeling · Standard review	Approved	Letter
Aug 2, 2002	Supplement 34Labeling · Standard review	Approved	Letter
Jul 10, 2002	Supplement 35Manufacturing · Standard review	Approved	Letter
Jul 26, 2001	Supplement 33Manufacturing · Standard review	Approved	None posted
May 25, 2001	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 28, 2001	Supplement 32Manufacturing · Standard review	Approved	None posted
Dec 19, 2000	Supplement 31Manufacturing · Standard review	Approved	None posted
Oct 4, 2000	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Review
Sep 21, 2000	Supplement 29Manufacturing · Standard review	Approved	None posted
Mar 16, 2000	Supplement 27Manufacturing · Standard review	Approved	None posted
Feb 29, 2000	Supplement 26Manufacturing · Standard review	Approved	None posted
Dec 16, 1998	Supplement 25Labeling · Standard review	Approved	Review
Sep 24, 1998	Supplement 24Manufacturing · Standard review	Approved	None posted
Sep 22, 1998	Supplement 23Manufacturing · Standard review	Approved	None posted
Feb 25, 1998	Supplement 22Manufacturing · Standard review	Approved	None posted
Dec 4, 1997	Supplement 21Manufacturing · Standard review	Approved	None posted
Nov 25, 1997	Supplement 20Manufacturing · Standard review	Approved	None posted
Sep 3, 1996	Supplement 19Labeling · Standard review	Approved	None posted
Mar 13, 1996	Supplement 18Manufacturing · Standard review	Approved	None posted
Jan 29, 1996	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 27, 1995	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 22, 1995	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 22, 1995	Supplement 10Efficacy (new indication or use) · Standard review	Approved	None posted
Jul 13, 1995	Supplement 14Labeling · Standard review	Approved	None posted
Jul 13, 1995	Supplement 13Labeling · Standard review	Approved	None posted
May 5, 1995	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 1, 1995	Supplement 9Labeling · Standard review	Approved	None posted
Oct 21, 1994	Supplement 11Labeling · Standard review	Approved	None posted
Jan 14, 1994	Supplement 8Labeling · Standard review	Approved	None posted
May 20, 1993	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 8, 1993	Supplement 6Labeling · Standard review	Approved	None posted
Jun 25, 1992	Supplement 5Labeling	Approved	None posted
May 18, 1992	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 9, 1992	Supplement 3Manufacturing · Standard review	Approved	None posted
May 20, 1991	Supplement 2Manufacturing · Standard review	Approved	None posted
May 20, 1991	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 28, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Show all 52

Identifiers

Application: NDA 19901
Drugs@FDA: Overview at FDA
Company: King 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