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FDA ANDA · ANDA091539

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Sponsor: WATSON LABS INC

APPLICATION
ANDA091539
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-22
LATEST ACTION
2022-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IRBESARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 150MG · TABLET · ORAL
IRBESARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 300MG · TABLET · ORAL

Approval history

2022-02-28Labeling · Supplement 2 · standardAP
2012-10-22OriginalAP
2012-10-22OriginalTA
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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