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FDA NDA · NDA020496

AMARYL

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA020496
TYPE
NDA
ORIGINAL APPROVAL
1995-11-30
LATEST ACTION
2018-12-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMARYL · ReferenceDiscontinued
GLIMEPIRIDE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AMARYL · ReferenceDiscontinued
GLIMEPIRIDE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AMARYL · ReferenceDiscontinued
GLIMEPIRIDE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2018-12-21Labeling · Supplement 29 · standard — Label ↗AP
2016-12-19Labeling · Supplement 28 · standard — Letter ↗AP
2013-10-15Labeling · Supplement 27 · standard — Label ↗AP
2013-08-01Labeling · Supplement 26 · standard — Label ↗AP
2013-04-19Manufacturing (CMC) · Supplement 25 · standardAP
2013-03-14Manufacturing (CMC) · Supplement 24 · standardAP
2012-02-03Labeling · Supplement 22 · standard — Letter ↗AP
2009-06-04Labeling · Supplement 21 · standard — Letter ↗AP
2009-02-03Labeling · Supplement 19 · standard — Label ↗AP
2009-02-03Labeling · Supplement 18 · standard — Letter ↗AP
2005-11-28Efficacy · Supplement 15 · priority — Pediatric Medical Review ↗AP
2005-09-19Labeling · Supplement 16 · standard — Letter ↗AP
2004-08-16Labeling · Supplement 13 · standard — Letter ↗AP
2002-04-15Labeling · Supplement 7 · standard — Letter ↗AP
2001-07-21Manufacturing (CMC) · Supplement 11 · standardAP
2000-12-05Manufacturing (CMC) · Supplement 10 · standardAP
2000-09-27Efficacy · Supplement 5 · standard — Review ↗AP
2000-08-29Manufacturing (CMC) · Supplement 9 · standardAP
2000-01-06Manufacturing (CMC) · Supplement 6 · standardAP
1999-02-24Efficacy · Supplement 2 · standard — Review ↗AP
1998-09-16Manufacturing (CMC) · Supplement 4 · standardAP
1998-09-16Manufacturing (CMC) · Supplement 3 · standardAP
1997-07-28Manufacturing (CMC) · Supplement 1 · standardAP
1995-11-30Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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