FDA.reportPublic FDA data

Application 020582

Type
BLA
Sponsor
ORGANON USA INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020582Follistimfollitropin beta351(a)Disc2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOLLISTIMFOLLITROPIN ALFA/BETAINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS75 IU/VIALNoNo
002FOLLISTIMFOLLITROPIN ALFA/BETAINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS150 IU/VIALNoNo

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62269APPL2020-03-23
41445SUPPL2020-03-23
41444ORIG2020-03-23
25228SUPPL2020-03-23
25227SUPPL2020-03-23
25226ORIG2020-03-23
20734SUPPL2020-03-23
12771SUPPL2020-03-23
2780SUPPL2020-03-23