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FDA BLA · BLA021765

GONAL-F

Sponsor: EMD SERONO

APPLICATION
BLA021765
TYPE
BLA
ORIGINAL APPROVAL
2004-03-25
LATEST ACTION
2023-11-13
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

GONAL-FDiscontinued
FOLLITROPIN ALFA/BETA 150 IU/VIAL · INJECTABLE · SUBCUTANEOUS
GONAL-FDiscontinued
FOLLITROPIN ALFA/BETA 37.5 IU/VIAL · INJECTABLE · SUBCUTANEOUS
GONAL-F RFFPrescription
FOLLITROPIN ALFA/BETA 75 IU/VIAL · INJECTABLE · SUBCUTANEOUS

Approval history

2023-11-13Labeling · Supplement 51 · standard — Letter ↗AP
2020-12-31Labeling · Supplement 44 · standard — Label ↗AP
2020-12-31Labeling · Supplement 14 · unknown — Label ↗AP
2020-12-31Labeling · Supplement 13 · standard — Label ↗AP
2016-02-10Manufacturing (CMC) · Supplement 40 · standardAP
2015-11-17Manufacturing (CMC) · Supplement 11 · standardAP
2015-04-29Manufacturing (CMC) · Supplement 39 · standardAP
2014-08-11Manufacturing (CMC) · Supplement 35 · standardAP
2013-12-19Manufacturing (CMC) · Supplement 34 · standardAP
2013-12-11Manufacturing (CMC) · Supplement 32 · standardAP
2013-04-04Manufacturing (CMC) · Supplement 29 · standardAP
2013-02-19Manufacturing (CMC) · Supplement 26 · standardAP
2013-02-14Manufacturing (CMC) · Supplement 25 · standardAP
2013-02-08Manufacturing (CMC) · Supplement 24 · standardAP
2013-02-06Manufacturing (CMC) · Supplement 20 · standardAP
2013-01-31Manufacturing (CMC) · Supplement 22 · standardAP
2013-01-23Manufacturing (CMC) · Supplement 21 · standardAP
2013-01-17Manufacturing (CMC) · Supplement 18 · standardAP
2013-01-17Manufacturing (CMC) · Supplement 19 · standardAP
2007-07-05Labeling · Supplement 7 · standard — Label ↗AP
2005-12-20Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP
2004-03-25Type 3 - New Dosage Form · Original · standard — Review ↗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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