← FDA DRUG APPROVALS

FDA NDA · NDA200175

TRIBENZOR

olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

Sponsor: COSETTE

APPLICATION
NDA200175
TYPE
NDA
ORIGINAL APPROVAL
2010-07-23
LATEST ACTION
2020-10-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRIBENZOR · ReferencePrescription
AMLODIPINE BESYLATE EQ 10MG BASE, HYDROCHLOROTHIAZIDE 25MG, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
TRIBENZOR · ReferencePrescription
AMLODIPINE BESYLATE EQ 5MG BASE, HYDROCHLOROTHIAZIDE 25MG, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
TRIBENZOR · ReferencePrescription
AMLODIPINE BESYLATE EQ 5MG BASE, HYDROCHLOROTHIAZIDE 12.5MG, OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
TRIBENZOR · ReferencePrescription
AMLODIPINE BESYLATE EQ 10MG BASE, HYDROCHLOROTHIAZIDE 12.5MG, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
TRIBENZOR · ReferencePrescription
AMLODIPINE BESYLATE EQ 5MG BASE, HYDROCHLOROTHIAZIDE 12.5MG, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL

Approval history

2020-10-02Labeling · Supplement 33 · standard — Letter ↗AP
2020-08-20Labeling · Supplement 37 · standard — Label ↗AP
2017-01-05Labeling · Supplement 26 · standard — Label ↗AP
2016-11-01Labeling · Supplement 25 · standard — Label ↗AP
2015-09-16Manufacturing (CMC) · Supplement 23 · standardAP
2014-09-23Labeling · Supplement 20 · standard — Label ↗AP
2014-06-27Labeling · Supplement 19 · standard — Letter ↗AP
2014-06-20Manufacturing (CMC) · Supplement 17 · standardAP
2014-06-13Labeling · Supplement 18 · standard — Label ↗AP
2013-07-03Manufacturing (CMC) · Supplement 14 · standardAP
2013-07-03Labeling · Supplement 15 · standard — Label ↗AP
2013-05-06Manufacturing (CMC) · Supplement 13 · standardAP
2013-02-01Manufacturing (CMC) · Supplement 10 · standardAP
2012-12-10Labeling · Supplement 12 · standard — Label ↗AP
2012-09-28Labeling · Supplement 11 · unknown — Letter ↗AP
2012-01-19Labeling · Supplement 8 · unknown — Letter ↗AP
2011-11-01Labeling · Supplement 7 · unknown — Label ↗AP
2011-06-21Labeling · Supplement 3 · unknown — Letter ↗AP
2011-03-25Labeling · Supplement 1 · unknown — Letter ↗AP
2010-07-23Type 4 - New Combination · Original · standard — Label ↗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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