APPLICATION
ANDA084878
TYPE
ANDA
ORIGINAL APPROVAL
1977-01-31
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL
Approval history
2020-08-20Labeling · Supplement 50 · standardAP
2011-08-17Labeling · Supplement 46AP
2006-07-12Manufacturing (CMC) · Supplement 39AP
2006-07-12Manufacturing (CMC) · Supplement 40AP
2004-03-24Labeling · Supplement 36AP
1992-11-27Manufacturing (CMC) · Supplement 26AP
1992-07-28Labeling · Supplement 35AP
1991-03-28Manufacturing (CMC) · Supplement 29AP
1991-02-07Bioequivalence · Supplement 32AP
1989-04-25Labeling · Supplement 51AP
1989-04-25Labeling · Supplement 25AP
1988-11-29Labeling · Supplement 24AP
1985-12-20Manufacturing (CMC) · Supplement 20AP
1983-07-20Manufacturing (CMC) · Supplement 19AP
1982-08-09Manufacturing (CMC) · Supplement 14AP
1977-01-31OriginalAP
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.