APPLICATION
NDA019836
TYPE
NDA
ORIGINAL APPROVAL
1991-12-24
LATEST ACTION
1997-10-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SUPPRELINDiscontinued
HISTRELIN ACETATE EQ 1MG BASE/ML · INJECTABLE · INJECTION
SUPPRELINDiscontinued
HISTRELIN ACETATE EQ 0.2MG BASE/ML · INJECTABLE · INJECTION
SUPPRELINDiscontinued
HISTRELIN ACETATE EQ 0.5MG BASE/ML · INJECTABLE · INJECTION
Approval history
1997-10-23Manufacturing (CMC) · Supplement 3 · priorityAP
1997-10-17Manufacturing (CMC) · Supplement 2 · priorityAP
1997-09-11Manufacturing (CMC) · Supplement 1 · priorityAP
1991-12-24Type 1 - New Molecular Entity · Original · priorityAP
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.