APPLICATION
NDA019415
TYPE
NDA
ORIGINAL APPROVAL
1986-09-18
LATEST ACTION
2002-04-15
ROUTE
SUBCUTANEOUS, INTRAMUSCULAR
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FERTINEXDiscontinued
UROFOLLITROPIN 150 IU/AMP · INJECTABLE · SUBCUTANEOUS
METRODINDiscontinued
UROFOLLITROPIN 75 IU/AMP · INJECTABLE · INTRAMUSCULAR
FERTINEXDiscontinued
UROFOLLITROPIN 75 IU/AMP · INJECTABLE · SUBCUTANEOUS
METRODINDiscontinued
UROFOLLITROPIN 150 IU/AMP · INJECTABLE · INTRAMUSCULAR
Approval history
2002-04-15Manufacturing (CMC) · Supplement 30 · standardAP
2000-12-28Manufacturing (CMC) · Supplement 28 · standardAP
2000-08-31Manufacturing (CMC) · Supplement 26 · standardAP
2000-07-18Manufacturing (CMC) · Supplement 25 · standardAP
2000-06-19Manufacturing (CMC) · Supplement 27 · standardAP
2000-01-21Manufacturing (CMC) · Supplement 24 · standardAP
1999-11-24Labeling · Supplement 21 · standardAP
1999-05-20Manufacturing (CMC) · Supplement 23 · standardAP
1999-04-01Manufacturing (CMC) · Supplement 22 · standardAP
1998-04-15Manufacturing (CMC) · Supplement 18 · standardAP
1998-02-18Manufacturing (CMC) · Supplement 17 · standardAP
1996-08-23Efficacy · Supplement 9AP
1996-08-22Manufacturing (CMC) · Supplement 16 · standardAP
1996-01-22Manufacturing (CMC) · Supplement 15 · standardAP
1995-08-29Efficacy · Supplement 13 · unknownAP
1995-07-12Labeling · Supplement 14 · standardAP
1994-05-31Manufacturing (CMC) · Supplement 8 · standardAP
1994-03-28Labeling · Supplement 10AP
1994-01-24Labeling · Supplement 11 · standardAP
1993-12-06Manufacturing (CMC) · Supplement 12 · standardAP
1991-01-17Manufacturing (CMC) · Supplement 6 · standardAP
1990-03-14Manufacturing (CMC) · Supplement 4 · standardAP
1988-04-25Labeling · Supplement 2AP
1988-03-01Efficacy · Supplement 1AP
1986-09-18Type 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.
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.