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FDA ANDA · ANDA203500

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Sponsor: DR REDDYS LABS LTD

APPLICATION
ANDA203500
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-27
LATEST ACTION
2012-09-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2012-09-27UNKNOWN · OriginalAP
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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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