FDA BLA · BLA020378

GONAL-F

follitropin alfa

Sponsor: EMD SERONO

APPLICATION

BLA020378

TYPE

BLA

ORIGINAL APPROVAL

1997-09-29

LATEST ACTION

2023-11-21

ROUTE

SUBCUTANEOUS

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued, Prescription

Products

GONAL-FDiscontinued

FOLLITROPIN ALFA/BETA 150 IU/VIAL · INJECTABLE · SUBCUTANEOUS

GONAL-FPrescription

FOLLITROPIN ALFA/BETA 450 IU/VIAL · INJECTABLE · SUBCUTANEOUS

GONAL-FDiscontinued

FOLLITROPIN ALFA/BETA 37.5 IU/VIAL · INJECTABLE · SUBCUTANEOUS

GONAL-FDiscontinued

FOLLITROPIN ALFA/BETA 75 IU/VIAL · INJECTABLE · SUBCUTANEOUS

GONAL-FPrescription

FOLLITROPIN ALFA/BETA 1,050 IU/VIAL · INJECTABLE · SUBCUTANEOUS

Approval history

2023-11-21Labeling · Supplement 84 · standard — Label ↗AP

2020-12-31Labeling · Supplement 75 · standard — Label ↗AP

2020-12-31Labeling · Supplement 67 · standard — Label ↗AP

2020-12-31Labeling · Supplement 45 · unknown — Label ↗AP

2016-11-15Manufacturing (CMC) · Supplement 72 · standardAP

2016-02-29Manufacturing (CMC) · Supplement 58 · standardAP

2015-11-19Manufacturing (CMC) · Supplement 43 · standardAP

2015-03-03Manufacturing (CMC) · Supplement 69 · standardAP

2015-02-09Manufacturing (CMC) · Supplement 68 · standardAP

2014-08-11Manufacturing (CMC) · Supplement 65 · standardAP

2014-01-30Manufacturing (CMC) · Supplement 61 · standardAP

2013-12-19Manufacturing (CMC) · Supplement 64 · standardAP

2013-12-11Manufacturing (CMC) · Supplement 63 · standardAP

2013-09-20Manufacturing (CMC) · Supplement 62 · standardAP

2013-08-13Manufacturing (CMC) · Supplement 42 · standardAP

2013-04-04Manufacturing (CMC) · Supplement 60 · standardAP

2013-02-26Manufacturing (CMC) · Supplement 59 · standardAP

2013-02-20Manufacturing (CMC) · Supplement 57 · standardAP

2013-02-19Manufacturing (CMC) · Supplement 56 · standardAP

2013-02-15Manufacturing (CMC) · Supplement 53 · standardAP

2013-02-14Manufacturing (CMC) · Supplement 55 · standardAP

2013-02-08Manufacturing (CMC) · Supplement 54 · standardAP

2013-02-06Manufacturing (CMC) · Supplement 50 · standardAP

2013-01-31Manufacturing (CMC) · Supplement 52 · standardAP

2013-01-23Manufacturing (CMC) · Supplement 51 · standardAP

2013-01-18Manufacturing (CMC) · Supplement 47 · standardAP

2004-03-25Manufacturing (CMC) · Supplement 15 · standard — Letter ↗AP

2003-07-16Labeling · Supplement 26 · standard — Letter ↗AP

2003-07-16Labeling · Supplement 29 · standard — Letter ↗AP

2002-10-16Manufacturing (CMC) · Supplement 21 · standardAP

2002-10-08Manufacturing (CMC) · Supplement 20 · standardAP

2002-10-07Manufacturing (CMC) · Supplement 19 · standardAP

2002-07-15Manufacturing (CMC) · Supplement 17 · standardAP

2001-07-23Manufacturing (CMC) · Supplement 14 · standardAP

2001-03-26Manufacturing (CMC) · Supplement 13 · standardAP

2001-02-28Manufacturing (CMC) · Supplement 9 · standardAP

2000-11-08Manufacturing (CMC) · Supplement 11 · standardAP

2000-10-26Manufacturing (CMC) · Supplement 12 · standardAP

2000-08-31Manufacturing (CMC) · Supplement 10 · standardAP

2000-05-25Manufacturing (CMC) · Supplement 3 · standardAP

VIEW ON DRUGS@FDA ↗

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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Approval history

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