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FDA BLA · BLA021273

FOLLISTIM AQ

Sponsor: ORGANON USA INC

APPLICATION
BLA021273
TYPE
BLA
ORIGINAL APPROVAL
2005-08-26
LATEST ACTION
2015-09-10
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

FOLLISTIM AQDiscontinued
FOLLITROPIN ALFA/BETA 150 IU/0.5ML · INJECTABLE · SUBCUTANEOUS
FOLLISTIM AQDiscontinued
FOLLITROPIN ALFA/BETA 75 IU/0.5ML · INJECTABLE · SUBCUTANEOUS

Approval history

2015-09-10Manufacturing (CMC) · Supplement 11 · standardAP
2013-11-19Manufacturing (CMC) · Supplement 9 · standardAP
2010-06-28Efficacy · Supplement 6 · standard — Label ↗AP
2008-12-24Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2006-08-08Manufacturing (CMC) · Supplement 1AP
2005-08-26Type 3 - New Dosage Form · Original · standard — Letter ↗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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