← FDA DRUG APPROVALS

FDA ANDA · ANDA090815

IRBESARTAN; HYDROCHLOROTHIAZIDE

Sponsor: ZYDUS PHARMS USA INC

APPLICATION
ANDA090815
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

IRBESARTAN; HYDROCHLOROTHIAZIDENone (Tentative Approval)
IRBESARTAN 300MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
IRBESARTAN; HYDROCHLOROTHIAZIDENone (Tentative Approval)
IRBESARTAN 150MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
IRBESARTAN; HYDROCHLOROTHIAZIDENone (Tentative Approval)
IRBESARTAN 300MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL

Approval history

2011-02-16OriginalTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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