← FDA DRUG APPROVALS

FDA NDA · NDA019901

ALTACE

Sponsor: KING PHARMS LLC

APPLICATION
NDA019901
TYPE
NDA
ORIGINAL APPROVAL
1991-01-28
LATEST ACTION
2026-05-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ALTACE · ReferenceDiscontinued
RAMIPRIL 10MG · CAPSULE · ORAL
ALTACE · ReferenceDiscontinued
RAMIPRIL 2.5MG · CAPSULE · ORAL
ALTACE · ReferenceDiscontinued
RAMIPRIL 5MG · CAPSULE · ORAL
ALTACE · ReferenceDiscontinued
RAMIPRIL 1.25MG · CAPSULE · ORAL

Approval history

2026-05-07Labeling · Supplement 72 · standard — Letter ↗AP
2017-04-26Labeling · Supplement 67 · standard — Label ↗AP
2015-09-11Labeling · Supplement 65 · standard — Letter ↗AP
2014-05-02Labeling · Supplement 64 · standard — Letter ↗AP
2013-11-04Labeling · Supplement 62 · standard — Letter ↗AP
2013-10-25Labeling · Supplement 63 · standard — Label ↗AP
2013-09-23Labeling · Supplement 60 · standard — Letter ↗AP
2012-04-11Labeling · Supplement 59 · unknown — Label ↗AP
2011-08-23Labeling · Supplement 58 · unknown — Label ↗AP
2010-10-21Labeling · Supplement 55 · standard — Label ↗AP
2009-03-04Labeling · Supplement 52 · standard — Letter ↗AP
2009-02-09Labeling · Supplement 54 · standard — Letter ↗AP
2004-11-15Labeling · Supplement 46 · standard — Letter ↗AP
2004-10-15Labeling · Supplement 43 · standard — Letter ↗AP
2004-10-15Labeling · Supplement 41 · standard — Letter ↗AP
2004-10-15Labeling · Supplement 40 · standard — Letter ↗AP
2002-08-02Labeling · Supplement 34 · standard — Letter ↗AP
2002-07-10Manufacturing (CMC) · Supplement 35 · standard — Letter ↗AP
2001-07-26Manufacturing (CMC) · Supplement 33 · standardAP
2001-05-25Manufacturing (CMC) · Supplement 30 · standardAP
2001-03-28Manufacturing (CMC) · Supplement 32 · standardAP
2000-12-19Manufacturing (CMC) · Supplement 31 · standardAP
2000-10-04Efficacy · Supplement 28 · standard — Review ↗AP
2000-09-21Manufacturing (CMC) · Supplement 29 · standardAP
2000-03-16Manufacturing (CMC) · Supplement 27 · standardAP
2000-02-29Manufacturing (CMC) · Supplement 26 · standardAP
1998-12-16Labeling · Supplement 25 · standard — Review ↗AP
1998-09-24Manufacturing (CMC) · Supplement 24 · standardAP
1998-09-22Manufacturing (CMC) · Supplement 23 · standardAP
1998-02-25Manufacturing (CMC) · Supplement 22 · standardAP
1997-12-04Manufacturing (CMC) · Supplement 21 · standardAP
1997-11-25Manufacturing (CMC) · Supplement 20 · standardAP
1996-09-03Labeling · Supplement 19 · standardAP
1996-03-13Manufacturing (CMC) · Supplement 18 · standardAP
1996-01-29Manufacturing (CMC) · Supplement 16 · standardAP
1995-09-27Manufacturing (CMC) · Supplement 17 · standardAP
1995-08-22Efficacy · Supplement 10 · standardAP
1995-08-22Manufacturing (CMC) · Supplement 12 · standardAP
1995-07-13Labeling · Supplement 13 · standardAP
1995-07-13Labeling · Supplement 14 · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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