APPLICATION
ANDA087059
TYPE
ANDA
ORIGINAL APPROVAL
1980-11-05
LATEST ACTION
2023-10-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
Approval history
2023-10-23Labeling · Supplement 22 · standardAP
2020-08-20Labeling · Supplement 20 · standardAP
2005-05-18Labeling · Supplement 17AP
1999-05-07Manufacturing (CMC) · Supplement 15AP
1999-02-11Manufacturing (CMC) · Supplement 14AP
1998-12-30Manufacturing (CMC) · Supplement 13AP
1995-08-03Labeling · Supplement 12AP
1994-07-12Manufacturing (CMC) · Supplement 8AP
1994-07-12Manufacturing (CMC) · Supplement 11AP
1993-11-22Labeling · Supplement 10AP
1993-08-10Labeling · Supplement 9AP
1992-05-26Labeling · Supplement 7AP
1990-04-20Labeling · Supplement 6AP
1989-11-15Labeling · Supplement 5AP
1983-07-27Manufacturing (CMC) · Supplement 4AP
1980-11-05OriginalAP
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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