← FDA DRUG APPROVALS

FDA BLA · BLA021684

GONAL-F RFF REDI-JECT

follitropin

Sponsor: EMD SERONO

APPLICATION
BLA021684
TYPE
BLA
ORIGINAL APPROVAL
2004-05-25
LATEST ACTION
2024-05-13
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

GONAL-F RFF REDI-JECTPrescription
FOLLITROPIN ALFA/BETA 900 IU/1.5ML · INJECTABLE · SUBCUTANEOUS
GONAL-F RFF REDI-JECTPrescription
FOLLITROPIN ALFA/BETA 300 IU/0.5ML · INJECTABLE · SUBCUTANEOUS
GONAL-F RFF REDI-JECTPrescription
FOLLITROPIN ALFA/BETA 150 IU/0.25ML · INJECTABLE · SUBCUTANEOUS
GONAL-F RFF REDI-JECTPrescription
FOLLITROPIN ALFA/BETA 450 IU/0.75ML · INJECTABLE · SUBCUTANEOUS

Approval history

2024-05-13Labeling · Supplement 50 · standard — Letter ↗AP
2024-05-13Labeling · Supplement 51 · standard — Letter ↗AP
2017-11-06Manufacturing (CMC) · Supplement 38AP
2013-10-16Manufacturing (CMC) · Supplement 36 — Label ↗AP
2013-04-04Manufacturing (CMC) · Supplement 33 · standardAP
2013-02-19Manufacturing (CMC) · Supplement 29 · standardAP
2013-02-14Manufacturing (CMC) · Supplement 28 · standardAP
2013-02-08Manufacturing (CMC) · Supplement 27 · standardAP
2013-02-06Manufacturing (CMC) · Supplement 23 · standardAP
2013-01-31Manufacturing (CMC) · Supplement 25 · standardAP
2013-01-23Manufacturing (CMC) · Supplement 24 · standardAP
2013-01-11Manufacturing (CMC) · Supplement 19 · standardAP
2007-12-18Labeling · Supplement 7 · standard — Letter ↗AP
2007-12-06Manufacturing (CMC) · Supplement 8 — Letter ↗AP
2004-05-25Type 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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