APPLICATION
BLA017646
TYPE
BLA
ORIGINAL APPROVAL
1975-08-22
LATEST ACTION
2002-07-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PERGONALDiscontinued
MENOTROPINS (FSH 75 IU/AMP, LH) 75 IU/AMP · INJECTABLE · INJECTION
PERGONALDiscontinued
MENOTROPINS (FSH 150 IU/AMP, LH) 150 IU/AMP · INJECTABLE · INJECTION
Approval history
2001-12-20Manufacturing (CMC) · Supplement 51 · standardAP
2000-10-12Manufacturing (CMC) · Supplement 47 · standardAP
2000-08-31Manufacturing (CMC) · Supplement 48 · standardAP
1999-05-20Manufacturing (CMC) · Supplement 46 · standardAP
1998-02-18Manufacturing (CMC) · Supplement 43 · standardAP
1998-02-17Manufacturing (CMC) · Supplement 44 · standardAP
1996-08-22Manufacturing (CMC) · Supplement 42 · standardAP
1996-01-22Manufacturing (CMC) · Supplement 40 · standardAP
1995-04-05Labeling · Supplement 39 · standardAP
1994-10-31Labeling · Supplement 38 · standardAP
1994-10-21Labeling · Supplement 36 · standardAP
1994-05-31Manufacturing (CMC) · Supplement 32 · standardAP
1993-12-06Manufacturing (CMC) · Supplement 37 · standardAP
1993-06-09Manufacturing (CMC) · Supplement 33 · standardAP
1991-01-17Manufacturing (CMC) · Supplement 31 · standardAP
1990-02-28Manufacturing (CMC) · Supplement 29 · standardAP
1989-08-23Efficacy · Supplement 21AP
1988-04-18Labeling · Supplement 28AP
1987-12-04Manufacturing (CMC) · Supplement 27 · standardAP
1986-09-15Labeling · Supplement 20AP
1986-03-18Manufacturing (CMC) · Supplement 26 · standardAP
1985-08-23Manufacturing (CMC) · Supplement 25 · standardAP
1985-07-29Manufacturing (CMC) · Supplement 23 · standardAP
1985-05-20Manufacturing (CMC) · Supplement 24 · standardAP
1985-05-20Manufacturing (CMC) · Supplement 22 · standardAP
1983-07-18Manufacturing (CMC) · Supplement 18 · standardAP
1983-07-18Labeling · Supplement 14AP
1983-07-11Manufacturing (CMC) · Supplement 16 · standardAP
1982-02-11Labeling · Supplement 13AP
1982-01-20Labeling · Supplement 1AP
1981-10-22Manufacturing (CMC) · Supplement 11 · standardAP
1980-10-28Manufacturing (CMC) · Supplement 10 · standardAP
1979-10-26Manufacturing (CMC) · Supplement 5 · standardAP
1975-08-22Type 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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