APPLICATION
ANDA040907
TYPE
ANDA
ORIGINAL APPROVAL
2008-08-15
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL
Approval history
2020-08-20Labeling · Supplement 18 · standardAP
2016-03-07Manufacturing (CMC) · Supplement 9 · unknownAP
2011-11-14Labeling · Supplement 4AP
2008-08-15OriginalAP
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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