FDA BLA · BLA021289

BRAVELLE

Sponsor: FERRING

APPLICATION

BLA021289

TYPE

BLA

ORIGINAL APPROVAL

2002-05-06

LATEST ACTION

2015-10-27

ROUTE

INTRAMUSCULAR, SUBCUTANEOUS

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

BRAVELLEDiscontinued

UROFOLLITROPIN 75 IU/VIAL · INJECTABLE · INTRAMUSCULAR, SUBCUTANEOUS

2015-10-27Manufacturing (CMC) · Supplement 27 · standardAP

2015-09-10Manufacturing (CMC) · Supplement 25 · standardAP

2015-07-27Manufacturing (CMC) · Supplement 26 · standardAP

2014-07-18Manufacturing (CMC) · Supplement 22 · standardAP

2014-07-11Manufacturing (CMC) · Supplement 21 · standardAP

2014-02-19Efficacy · Supplement 19 · standard — Letter ↗AP

2002-11-14Manufacturing (CMC) · Supplement 2 · standardAP

2002-05-06Type 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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