← FDA DRUG APPROVALS

FDA NDA · NDA022100

AZOR

amlodipine besylate and olmesartan medoxomil

Sponsor: COSETTE

APPLICATION
NDA022100
TYPE
NDA
ORIGINAL APPROVAL
2007-09-26
LATEST ACTION
2020-10-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AZOR · ReferencePrescription
AMLODIPINE BESYLATE EQ 5MG BASE, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
AZOR · ReferencePrescription
AMLODIPINE BESYLATE EQ 10MG BASE, OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
AZOR · ReferencePrescription
AMLODIPINE BESYLATE EQ 5MG BASE, OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
AZOR · ReferencePrescription
AMLODIPINE BESYLATE EQ 10MG BASE, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL

Approval history

2020-10-02Labeling · Supplement 39 · standard — Letter ↗AP
2017-01-05Labeling · Supplement 33 · standard — Label ↗AP
2016-12-09Labeling · Supplement 30 · standard — Letter ↗AP
2016-11-01Labeling · Supplement 32 · standard — Label ↗AP
2016-07-08Manufacturing (CMC) · Supplement 29 · standardAP
2015-07-09Manufacturing (CMC) · Supplement 27 · standardAP
2015-06-04Manufacturing (CMC) · Supplement 28 · standardAP
2014-09-23Labeling · Supplement 26 · standard — Letter ↗AP
2014-07-02Labeling · Supplement 25 · standard — Label ↗AP
2014-06-13Labeling · Supplement 24 · standard — Label ↗AP
2014-05-14Manufacturing (CMC) · Supplement 23 · standardAP
2013-07-03Labeling · Supplement 22 · standard — Letter ↗AP
2013-02-01Manufacturing (CMC) · Supplement 18 · standardAP
2012-12-11Labeling · Supplement 20 · standard — Label ↗AP
2012-09-28Labeling · Supplement 19 · unknown — Label ↗AP
2012-01-18Labeling · Supplement 16 · unknown — Label ↗AP
2011-11-14Labeling · Supplement 13 · unknown — Label ↗AP
2011-11-02Labeling · Supplement 14 · unknown — Label ↗AP
2011-05-19Labeling · Supplement 12 · unknown — Letter ↗AP
2011-05-19Labeling · Supplement 10 · unknown — Letter ↗AP
2009-05-11Efficacy · Supplement 2 · unknown — Label ↗AP
2008-08-07Labeling · Supplement 3 · standard — Letter ↗AP
2007-09-26Type 4 - New Combination · 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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