APPLICATION
NDA012775
TYPE
NDA
ORIGINAL APPROVAL
1961-08-01
LATEST ACTION
1998-04-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ENDURONYLDiscontinued
DESERPIDINE 0.25MG, METHYCLOTHIAZIDE 5MG · TABLET · ORAL
ENDURONYL FORTEDiscontinued
DESERPIDINE 0.5MG, METHYCLOTHIAZIDE 5MG · TABLET · ORAL
Approval history
1998-04-16Manufacturing (CMC) · Supplement 36 · standardAP
1991-09-25Labeling · Supplement 35 · standardAP
1991-09-25Labeling · Supplement 33 · standardAP
1987-11-17Manufacturing (CMC) · Supplement 34 · standardAP
1986-08-29Manufacturing (CMC) · Supplement 32 · standardAP
1986-07-28Manufacturing (CMC) · Supplement 31 · standardAP
1984-01-05Labeling · Supplement 30 · standardAP
1982-08-25Labeling · Supplement 29 · standardAP
1981-10-05Manufacturing (CMC) · Supplement 27 · standardAP
1981-05-22Manufacturing (CMC) · Supplement 26 · standardAP
1981-03-27Manufacturing (CMC) · Supplement 25 · standardAP
1980-12-12Manufacturing (CMC) · Supplement 24 · standardAP
1980-01-03Labeling · Supplement 23 · standardAP
1961-08-01Type 4 - New Combination · Original · standardAP
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.