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FDA ANDA · ANDA216211
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Sponsor: RUBICON RESEARCH
APPLICATION
ANDA216211
TYPE
ANDA
ORIGINAL APPROVAL
2022-02-23
LATEST ACTION
2022-02-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRIAMTERENE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 50MG, TRIAMTERENE 75MG · TABLET · ORAL
TRIAMTERENE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, TRIAMTERENE 37.5MG · TABLET · ORAL
Approval history
2022-02-23UNKNOWN · 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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