APPLICATION
NDA019687
TYPE
NDA
ORIGINAL APPROVAL
1989-10-10
LATEST ACTION
1993-12-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LUTREPULSE KITDiscontinued
GONADORELIN ACETATE 3.2MG/VIAL · INJECTABLE · INJECTION
LUTREPULSE KITDiscontinued
GONADORELIN ACETATE 0.8MG/VIAL · INJECTABLE · INJECTION
Approval history
1993-12-02Labeling · Supplement 13 · standardAP
1993-04-05Labeling · Supplement 12 · standardAP
1992-08-21Manufacturing (CMC) · Supplement 6 · standardAP
1992-03-13Manufacturing (CMC) · Supplement 9 · standardAP
1992-03-09Manufacturing (CMC) · Supplement 11 · standardAP
1991-08-07Labeling · Supplement 8AP
1991-06-10Labeling · Supplement 2AP
1990-07-18Manufacturing (CMC) · Supplement 3 · standardAP
1989-11-27Manufacturing (CMC) · Supplement 1 · standardAP
1989-10-10Type 2 - New Active Ingredient · 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.
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