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
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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