FDA.reportPublic FDA data

Application 017646

Type
BLA
Sponsor
SERONO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
017646Pergonalmenotropins351(a)Disc2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PERGONALMENOTROPINS (FSH;LH)INJECTABLE;INJECTION75 IU/AMP;75 IU/AMPNoNo
002PERGONALMENOTROPINS (FSH;LH)INJECTABLE;INJECTION150 IU/AMP;150 IU/AMPNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66387APPL2020-03-23
13874SUPPL2020-03-23