FDA.reportPublic FDA data

Application 020378

Type
BLA
Sponsor
EMD SERONO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020378Gonal-ffollitropin alfa351(a)Disc2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GONAL-FFOLLITROPIN ALFA/BETAINJECTABLE;SUBCUTANEOUS75 IU/VIALNoNo
002GONAL-FFOLLITROPIN ALFA/BETAINJECTABLE;SUBCUTANEOUS150 IU/VIALNoNo
003GONAL-FFOLLITROPIN ALFA/BETAINJECTABLE;SUBCUTANEOUS37.5 IU/VIALNoNo
004GONAL-FFOLLITROPIN ALFA/BETAINJECTABLE;SUBCUTANEOUS1,050 IU/VIALNoNo
005GONAL-FFOLLITROPIN ALFA/BETAINJECTABLE;SUBCUTANEOUS450 IU/VIALNoNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gonal-fFOLLITROPIN ALFAEMD Serono, Inc.ae85b9c3-e7eb-4981-a5d9-346050e8f1892025-09-02Warnings, Adverse reactionsExact identifier
application number: BLA020378
ndc (product): 44087-9070
ndc (product): 44087-9030

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44087-9030Gonal-ffollitropin alfaEMD Serono, Inc.BLACurrent
44087-9030Gonal-ffollitropin alfaEMD Serono, Inc.BLACurrent
44087-9030Gonal-ffollitropin alfaEMD Serono, Inc.NDACurrent
44087-9030Gonal-ffollitropin alfaEMD Serono, Inc.NDACurrent
44087-9030Gonal-ffollitropin alfaEMD Serono, Inc.NDACurrent
44087-9030Gonal-ffollitropin alfaEMD Serono, Inc.BLACurrent
44087-9070Gonal-ffollitropin alfaEMD Serono, Inc.BLACurrent
44087-9070Gonal-ffollitropin alfaEMD Serono, Inc.BLACurrent
44087-9070Gonal-ffollitropin alfaEMD Serono, Inc.NDACurrent
44087-9070Gonal-ffollitropin alfaEMD Serono, Inc.NDACurrent
44087-9070Gonal-ffollitropin alfaEMD Serono, Inc.NDACurrent
44087-9070Gonal-ffollitropin alfaEMD Serono, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76654SUPPL 2023-11-24
76648SUPPL 2023-11-22
65812SUPPL2021-01-04
65811SUPPL2021-01-04
65810SUPPL2021-01-04
65803SUPPL2020-12-31
65802SUPPL2020-12-31
65801SUPPL2020-12-31
62260APPL2020-03-23
41314SUPPL2020-03-23
34573SUPPL2020-03-23
24869SUPPL2020-03-23
24868SUPPL2020-03-23
2423SUPPL2020-03-23
2422SUPPL2020-03-23