APPLICATION
ANDA083177
TYPE
ANDA
ORIGINAL APPROVAL
1973-01-12
LATEST ACTION
2024-09-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROCHLOROTHIAZIDE · ReferencePrescription
HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL
HYDROCHLOROTHIAZIDE · ReferencePrescription
HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
HYDROCHLOROTHIAZIDE · ReferencePrescription
HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
Approval history
2024-09-19Manufacturing (CMC) · Supplement 236 · unknownAP
2020-08-20Labeling · Supplement 229 · standardAP
2012-01-19Labeling · Supplement 221AP
2005-01-07Labeling · Supplement 205AP
2004-07-07Labeling · Supplement 200AP
2002-11-15Manufacturing (CMC) · Supplement 196AP
2002-08-22Manufacturing (CMC) · Supplement 193AP
2002-07-29Manufacturing (CMC) · Supplement 197AP
2001-09-12Manufacturing (CMC) · Supplement 195AP
2000-02-03Labeling · Supplement 192AP
2000-02-03Manufacturing (CMC) · Supplement 190AP
2000-01-28Manufacturing (CMC) · Supplement 191AP
1999-04-30Manufacturing (CMC) · Supplement 187AP
1999-04-30Manufacturing (CMC) · Supplement 188AP
1999-04-30Manufacturing (CMC) · Supplement 186AP
1998-12-09Manufacturing (CMC) · Supplement 185AP
1998-05-13Manufacturing (CMC) · Supplement 184AP
1998-01-13Manufacturing (CMC) · Supplement 183AP
1997-05-30Manufacturing (CMC) · Supplement 182AP
1996-04-24Manufacturing (CMC) · Supplement 181AP
1995-10-06Manufacturing (CMC) · Supplement 177AP
1995-08-17Labeling · Supplement 180AP
1993-06-03Labeling · Supplement 179AP
1993-03-12Labeling · Supplement 178AP
1992-09-09Manufacturing (CMC) · Supplement 175AP
1992-09-09Manufacturing (CMC) · Supplement 176AP
1988-11-10Bioequivalence · Supplement 174AP
1988-03-31Manufacturing (CMC) · Supplement 170AP
1988-03-31Manufacturing (CMC) · Supplement 169AP
1987-06-29Manufacturing (CMC) · Supplement 168AP
1987-02-20Manufacturing (CMC) · Supplement 164AP
1987-01-14Manufacturing (CMC) · Supplement 165AP
1987-01-14Manufacturing (CMC) · Supplement 166AP
1982-03-30Manufacturing (CMC) · Supplement 156AP
1982-03-30Manufacturing (CMC) · Supplement 157AP
1982-03-30Manufacturing (CMC) · Supplement 158AP
1973-01-12OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.