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FDA BLA · BLA020582

FOLLISTIM

Sponsor: ORGANON USA INC

APPLICATION
BLA020582
TYPE
BLA
ORIGINAL APPROVAL
1997-09-29
LATEST ACTION
2002-07-10
ROUTE
INTRAMUSCULAR, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

FOLLISTIMDiscontinued
FOLLITROPIN ALFA/BETA 75 IU/VIAL · INJECTABLE · INTRAMUSCULAR, SUBCUTANEOUS
FOLLISTIMDiscontinued
FOLLITROPIN ALFA/BETA 150 IU/VIAL · INJECTABLE · INTRAMUSCULAR, SUBCUTANEOUS

Approval history

2002-07-10Manufacturing (CMC) · Supplement 8 · standardAP
2002-07-05Manufacturing (CMC) · Supplement 7 · standardAP
2002-02-26Efficacy · Supplement 6 · standard — Label ↗TA
2001-03-15Manufacturing (CMC) · Supplement 4 · standardAP
2000-05-25Manufacturing (CMC) · Supplement 5 · standardAP
2000-04-18Manufacturing (CMC) · Supplement 3 · standardAP
1999-03-26Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
1998-11-18Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
1997-09-29Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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