FDA.reportPublic FDA data

Application 020328

Type
BLA
Sponsor
ORGANON USA INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020328Humegonmenotropins351(a)Disc2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HUMEGONMENOTROPINS (FSH;LH)INJECTABLE;INJECTION75 IU/VIAL;75 IU/VIALNoNo
002HUMEGONMENOTROPINS (FSH;LH)INJECTABLE;INJECTION150 IU/VIAL;150 IU/VIALNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66385APPL2020-03-22