APPLICATION
ANDA085338
TYPE
ANDA
ORIGINAL APPROVAL
1978-04-10
LATEST ACTION
1982-08-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
H.R.-50Discontinued
HYDROCHLOROTHIAZIDE 50MG, RESERPINE 0.125MG · TABLET · ORAL
Approval history
1982-08-04Manufacturing (CMC) · Supplement 7AP
1982-04-19Manufacturing (CMC) · Supplement 6AP
1982-04-19Manufacturing (CMC) · Supplement 5AP
1978-04-10OriginalAP
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.