APPLICATION
BLA017055
TYPE
BLA
ORIGINAL APPROVAL
1974-12-13
LATEST ACTION
1998-01-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
A.P.L.Discontinued
GONADOTROPIN, CHORIONIC 5,000 UNITS/VIAL · INJECTABLE · INJECTION
A.P.L.Discontinued
GONADOTROPIN, CHORIONIC 10,000 UNITS/VIAL · INJECTABLE · INJECTION
A.P.L.Discontinued
GONADOTROPIN, CHORIONIC 20,000 UNITS/VIAL · INJECTABLE · INJECTION
Approval history
1998-01-23Labeling · Supplement 12 · standardAP
1994-05-02Labeling · Supplement 11 · standardAP
1991-08-13Manufacturing (CMC) · Supplement 10 · standardAP
1990-09-07Labeling · Supplement 8AP
1989-12-06Manufacturing (CMC) · Supplement 9 · standardAP
1989-04-17Manufacturing (CMC) · Supplement 7 · standardAP
1988-11-18Manufacturing (CMC) · Supplement 6 · standardAP
1988-02-24Manufacturing (CMC) · Supplement 4 · standardAP
1982-09-22Manufacturing (CMC) · Supplement 3 · standardAP
1982-02-03Manufacturing (CMC) · Supplement 2 · standardAP
1975-06-30Labeling · Supplement 1AP
1974-12-13Type 5 - New Formulation or New Manufacturer · 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.