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FDA NDA · NDA021093

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

Sponsor: ANI PHARMS

APPLICATION
NDA021093
TYPE
NDA
ORIGINAL APPROVAL
2000-09-05
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ATACAND HCT · ReferencePrescription
CANDESARTAN CILEXETIL 32MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
ATACAND HCT · ReferencePrescription
CANDESARTAN CILEXETIL 32MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
ATACAND HCT · ReferencePrescription
CANDESARTAN CILEXETIL 16MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL

Approval history

2020-08-20Labeling · Supplement 21 · standard — Letter ↗AP
2016-02-09Labeling · Supplement 19 · standard — Letter ↗AP
2015-02-09Labeling · Supplement 16 · unknown — Letter ↗AP
2013-04-26Labeling · Supplement 18 · standard — Label ↗AP
2012-03-29Labeling · Supplement 15 · unknown — Letter ↗AP
2011-06-14Labeling · Supplement 13 · unknown — Letter ↗AP
2011-03-11Labeling · Supplement 12 · unknown — Label ↗AP
2008-05-16Manufacturing (CMC) · Supplement 8 — Letter ↗AP
2006-08-17Labeling · Supplement 6 · standard — Label ↗AP
2004-12-16Labeling · Supplement 4 · standard — Letter ↗AP
2002-07-03Manufacturing (CMC) · Supplement 2 · standardAP
2001-11-28Labeling · Supplement 1 · standardAP
2000-09-05Type 4 - New Combination · 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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