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FDA BLA · BLA021663

MENOPUR

menotropins

Sponsor: FERRING

APPLICATION
BLA021663
TYPE
BLA
ORIGINAL APPROVAL
2004-10-29
LATEST ACTION
2016-07-08
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MENOPURPrescription
MENOTROPINS (FSH 75 IU/VIAL, LH) 75 IU/VIAL · INJECTABLE · SUBCUTANEOUS

Approval history

2016-07-08Manufacturing (CMC) · Supplement 26 · standardAP
2015-01-20Manufacturing (CMC) · Supplement 21 · standardAP
2014-07-11Manufacturing (CMC) · Supplement 19 · standardAP
2014-02-19Efficacy · Supplement 14 · standard — Label ↗AP
2013-06-11Manufacturing (CMC) · Supplement 16 · standardAP
2013-01-24Manufacturing (CMC) · Supplement 15 · standardAP
2006-03-20Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP
2006-03-20Labeling · Supplement 1 · standard — Label ↗AP
2004-10-29Type 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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