APPLICATION
BLA020328
TYPE
BLA
ORIGINAL APPROVAL
1994-09-01
LATEST ACTION
1999-11-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HUMEGONDiscontinued
MENOTROPINS (FSH 75 IU/VIAL, LH) 75 IU/VIAL · INJECTABLE · INJECTION
HUMEGONDiscontinued
MENOTROPINS (FSH 150 IU/VIAL, LH) 150 IU/VIAL · INJECTABLE · INJECTION
Approval history
1999-11-23Labeling · Supplement 4 · standardAP
1999-04-02Manufacturing (CMC) · Supplement 3 · standardAP
1997-02-21Manufacturing (CMC) · Supplement 2 · standardAP
1995-07-06Manufacturing (CMC) · Supplement 1 · standardAP
1994-09-01Type 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.
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