← FDA DRUG APPROVALS

FDA NDA · NDA020184

ACEON

Sponsor: SYMPLMED PHARMS LLC

APPLICATION
NDA020184
TYPE
NDA
ORIGINAL APPROVAL
1993-12-30
LATEST ACTION
2017-09-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACEON · ReferenceDiscontinued
PERINDOPRIL ERBUMINE 4MG · TABLET · ORAL
ACEON · ReferenceDiscontinued
PERINDOPRIL ERBUMINE 8MG · TABLET · ORAL
ACEON · ReferenceDiscontinued
PERINDOPRIL ERBUMINE 2MG · TABLET · ORAL

Approval history

2017-09-29Labeling · Supplement 23 · standard — Label ↗AP
2015-03-30Labeling · Supplement 22 · standard — Letter ↗AP
2013-02-26Labeling · Supplement 20 · standard — Letter ↗AP
2012-04-11Labeling · Supplement 19 · unknown — Label ↗AP
2011-08-23Labeling · Supplement 17 · unknown — Label ↗AP
2010-12-10Labeling · Supplement 15 · standard — Letter ↗AP
2008-09-03Labeling · Supplement 13 · standard — Letter ↗AP
2008-09-03Labeling · Supplement 14 · standard — Letter ↗AP
2005-08-23Efficacy · Supplement 11 · priority — Label ↗AP
2003-10-29Labeling · Supplement 9 · standard — Review ↗AP
2002-11-20Manufacturing (CMC) · Supplement 8 · standardAP
2002-08-14Manufacturing (CMC) · Supplement 7 · standardAP
1999-08-12Manufacturing (CMC) · Supplement 6 · standardAP
1997-08-21Manufacturing (CMC) · Supplement 5 · standardAP
1997-07-21Labeling · Supplement 4 · standardAP
1997-01-08Labeling · Supplement 3 · standard — Review ↗AP
1996-11-14Manufacturing (CMC) · Supplement 2 · standardAP
1994-05-13Manufacturing (CMC) · Supplement 1 · standardAP
1993-12-30Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
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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