APPLICATION
ANDA085182
TYPE
ANDA
ORIGINAL APPROVAL
1978-01-20
LATEST ACTION
2023-03-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL
Approval history
2023-03-16Labeling · Supplement 43 · standardAP
2020-08-20Labeling · Supplement 38 · standardAP
2020-07-29Labeling · Supplement 37 · standardAP
1986-04-17Manufacturing (CMC) · Supplement 18AP
1986-04-17Manufacturing (CMC) · Supplement 19AP
1985-11-29Manufacturing (CMC) · Supplement 16AP
1985-11-29Manufacturing (CMC) · Supplement 17AP
1985-11-29Manufacturing (CMC) · Supplement 15AP
1978-01-20OriginalAP
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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