← FDA DRUG APPROVALS

FDA NDA · NDA021286

BENICAR

olmesartan medoxomil

Sponsor: COSETTE

APPLICATION
NDA021286
TYPE
NDA
ORIGINAL APPROVAL
2002-04-25
LATEST ACTION
2019-10-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BENICAR · ReferencePrescription
OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
BENICAR · ReferencePrescription
OLMESARTAN MEDOXOMIL 5MG · TABLET · ORAL
BENICAR · ReferencePrescription
OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL

Approval history

2019-10-17Labeling · Supplement 40 · standard — Label ↗AP
2016-11-01Labeling · Supplement 36 · standard — Label ↗AP
2016-07-08Manufacturing (CMC) · Supplement 35 · standardAP
2016-06-10Manufacturing (CMC) · Supplement 34 · standardAP
2014-10-07Manufacturing (CMC) · Supplement 28 · standardAP
2014-09-23Labeling · Supplement 32 · standard — Letter ↗AP
2014-07-03Manufacturing (CMC) · Supplement 29 · standardAP
2014-06-27Labeling · Supplement 31 · standard — Letter ↗AP
2014-06-13Labeling · Supplement 30 · standard — Letter ↗AP
2013-07-03Labeling · Supplement 27 · standard — Label ↗AP
2013-02-01Manufacturing (CMC) · Supplement 24 · standardAP
2012-12-11Labeling · Supplement 26 · standard — Letter ↗AP
2012-09-28Labeling · Supplement 25 · unknown — Letter ↗AP
2012-03-29Labeling · Supplement 23 · unknown — Letter ↗AP
2012-02-15Labeling · Supplement 21 · unknown — Label ↗AP
2011-06-06Labeling · Supplement 20 · unknown — Letter ↗AP
2011-05-19Labeling · Supplement 19 · unknown — Letter ↗AP
2010-02-04Efficacy · Supplement 18 · priority — Label ↗AP
2007-09-26Labeling · Supplement 12 · standard — Letter ↗AP
2005-07-13Labeling · Supplement 10 · standard — Letter ↗AP
2004-11-12Labeling · Supplement 6 · standard — Letter ↗AP
2003-02-12Labeling · Supplement 2 · standard — Letter ↗AP
2002-10-25Labeling · Supplement 1 · standard — Letter ↗AP
2002-04-25Type 1 - New Molecular Entity · Original · standard — Letter ↗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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