FDA.reportPublic FDA data

Application 021273

Type
BLA
Sponsor
ORGANON USA INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021273Follistim AQfollitropin beta351(a)Disc2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOLLISTIM AQFOLLITROPIN ALFA/BETAINJECTABLE;SUBCUTANEOUS75 IU/0.5MLNoNo
002FOLLISTIM AQFOLLITROPIN ALFA/BETAINJECTABLE;SUBCUTANEOUS150 IU/0.5MLNoNo

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Follistim AQFOLLITROPINOrganon LLC48489027-e52b-4b10-ae74-4ba03839150c2026-05-26Warnings, Adverse reactionsName fallback
brand name: Follistim AQ

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62335APPL2020-03-25
36532ORIG2020-03-23
27312SUPPL2020-03-23
27311SUPPL2020-03-23
21565ORIG2020-03-23
14826SUPPL2020-03-23
4858ORIG2020-03-23