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FDA BLA · BLA021047

REPRONEX

Sponsor: FERRING

APPLICATION
BLA021047
TYPE
BLA
ORIGINAL APPROVAL
1999-08-27
LATEST ACTION
2015-03-03
ROUTE
INTRAMUSCULAR, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

REPRONEXDiscontinued
MENOTROPINS (FSH 75 IU/VIAL, LH) 75 IU/VIAL · INJECTABLE · INTRAMUSCULAR, SUBCUTANEOUS
REPRONEXDiscontinued
MENOTROPINS (FSH 150 IU/VIAL, LH) 150 IU/VIAL · INJECTABLE · INJECTION

Approval history

2015-03-03Manufacturing (CMC) · Supplement 14 · standardAP
2013-11-06Manufacturing (CMC) · Supplement 13 · standardAP
2001-10-23Manufacturing (CMC) · Supplement 2 · standardAP
2000-07-21Labeling · Supplement 1 · standard — Review ↗AP
1999-08-27UNKNOWN · Original · standard — Label ↗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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