Home Applications 021663 Application 021663
Type BLA
Sponsor FERRING Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 021663 Menopur menotropins 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MENOPUR MENOTROPINS (FSH;LH) INJECTABLE;SUBCUTANEOUS 75 IU/VIAL;75 IU/VIAL No No
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55566-7501 Menopur menotropins Ferring Pharmaceuticals Inc. NDA Current 55566-7501 Menopur menotropins Ferring Pharmaceuticals Inc. NDA Current 55566-7501 Menopur menotropins Ferring Pharmaceuticals Inc. BLA Current 55566-7501 Menopur menotropins Ferring Pharmaceuticals Inc. BLA Current 55566-7501 Menopur menotropins Ferring Pharmaceuticals Inc. BLA Current 55566-7501 Menopur menotropins Ferring Pharmaceuticals Inc. BLA Current 55566-7501 Menopur menotropins Ferring Pharmaceuticals Inc. BLA Current 55566-7501 Menopur menotropins Ferring Pharmaceuticals Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 66386 APPL 2020-03-23 37423 SUPPL 2020-03-23 28331 SUPPL 2020-03-23 28330 SUPPL 2020-03-23 21771 ORIG 2020-03-23 15941 SUPPL 2020-03-23 15940 SUPPL 2020-03-23 15939 ORIG 2020-03-23 5945 SUPPL 2020-03-23 5944 ORIG 2020-03-23