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FDA ANDA · ANDA208360

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA208360
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-29
LATEST ACTION
2020-12-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRIAMTERENE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, TRIAMTERENE 37.5MG · TABLET · ORAL
TRIAMTERENE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 50MG, TRIAMTERENE 75MG · TABLET · ORAL

Approval history

2020-12-10Labeling · Supplement 1 · standardAP
2018-06-29UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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