APPLICATION
ANDA078164
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-19
LATEST ACTION
2024-04-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG · CAPSULE · ORAL
Approval history
2024-04-04Labeling · Supplement 11 · standardAP
2014-10-28Labeling · Supplement 3AP
2007-09-19OriginalAP
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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