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FDA ANDA · ANDA091084

TELMISARTAN; HYDROCHLOROTHIAZIDE

Sponsor: WATSON LABS FLORIDA

APPLICATION
ANDA091084
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

TELMISARTAN; HYDROCHLOROTHIAZIDENone (Tentative Approval)
TELMISARTAN 80MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
TELMISARTAN; HYDROCHLOROTHIAZIDENone (Tentative Approval)
TELMISARTAN 80MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
TELMISARTAN; HYDROCHLOROTHIAZIDENone (Tentative Approval)
TELMISARTAN 40MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL

Approval history

2011-09-15OriginalTA
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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