APPLICATION
ANDA084466
TYPE
ANDA
ORIGINAL APPROVAL
1977-01-07
LATEST ACTION
1994-09-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCHLOROTHIAZIDE W/ RESERPINEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, RESERPINE 0.125MG · TABLET · ORAL
Approval history
1994-09-27Labeling · Supplement 28AP
1991-08-07Manufacturing (CMC) · Supplement 25AP
1991-07-25Labeling · Supplement 27AP
1990-11-19Manufacturing (CMC) · Supplement 26AP
1990-06-29Manufacturing (CMC) · Supplement 24AP
1989-12-19Labeling · Supplement 23AP
1988-07-18Manufacturing (CMC) · Supplement 19AP
1988-07-18Manufacturing (CMC) · Supplement 18AP
1988-07-18Manufacturing (CMC) · Supplement 20AP
1988-06-17Labeling · Supplement 22AP
1984-04-25Manufacturing (CMC) · Supplement 15AP
1982-10-01Manufacturing (CMC) · Supplement 12AP
1982-03-29Manufacturing (CMC) · Supplement 11AP
1981-12-30Manufacturing (CMC) · Supplement 9AP
1977-01-07OriginalAP
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.