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

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

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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