FDA.reportPublic FDA data

Application 021684

Type
BLA
Sponsor
EMD SERONO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021684Gonal-f RFF RediJectfollitropin alfa351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GONAL-F RFF REDI-JECTFOLLITROPIN ALFA/BETAINJECTABLE;SUBCUTANEOUS300 IU/0.5MLNoNo
002GONAL-F RFF REDI-JECTFOLLITROPIN ALFA/BETAINJECTABLE;SUBCUTANEOUS450 IU/0.75MLNoNo
003GONAL-F RFF REDI-JECTFOLLITROPIN ALFA/BETAINJECTABLE;SUBCUTANEOUS900 IU/1.5MLNoNo
004GONAL-F RFF REDI-JECTFOLLITROPIN ALFA/BETAINJECTABLE;SUBCUTANEOUS150 IU/0.25MLNoNo

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-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.b6d11c45-b502-478e-bb28-2ff596ea259c2025-04-03Warnings, Adverse reactionsExact identifier
application number: BLA021684
ndc (product): 44087-1117
ndc (product): 44087-1115
ndc (product): 44087-1116

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44087-1115Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.NDACurrent
44087-1115Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.BLACurrent
44087-1115Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.NDACurrent
44087-1115Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.BLACurrent
44087-1115Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.NDACurrent
44087-1116Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.NDACurrent
44087-1116Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.BLACurrent
44087-1116Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.NDACurrent
44087-1116Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.BLACurrent
44087-1116Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.NDACurrent
44087-1117Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.NDACurrent
44087-1117Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.BLACurrent
44087-1117Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.NDACurrent
44087-1117Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.BLACurrent
44087-1117Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.NDACurrent
44087-1118Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78474SUPPL 2024-05-15
78473SUPPL 2024-05-15
78454SUPPL 2024-05-14
78453SUPPL 2024-05-14
62268APPL2020-03-23
42269ORIG2020-03-23
37439SUPPL2020-03-23
37438ORIG2020-03-23
28353ORIG2020-03-23
15963SUPPL2020-03-23
5966SUPPL2020-03-23
5965SUPPL2020-03-23