Home Applications 021765 Application 021765
Type BLA
Sponsor EMD SERONO Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 021765 Gonal-f RFF follitropin alfa 351(a) Disc 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GONAL-F FOLLITROPIN ALFA/BETA INJECTABLE;SUBCUTANEOUS 37.5 IU/VIAL No No 002 GONAL-F RFF FOLLITROPIN ALFA/BETA INJECTABLE;SUBCUTANEOUS 75 IU/VIAL No No 003 GONAL-F FOLLITROPIN ALFA/BETA INJECTABLE;SUBCUTANEOUS 150 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gonal-f FOLLITROPIN ALFA EMD Serono, Inc. ae85b9c3-e7eb-4981-a5d9-346050e8f189 2025-09-02 Warnings, Adverse reactions Name fallback brand name: Gonal-f
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 44087-9005 GONAL-F RFF follitropin alfa EMD Serono, Inc. BLA Current 44087-9005 GONAL-F RFF follitropin alfa EMD Serono, Inc. NDA Current 44087-9005 GONAL-F RFF follitropin alfa EMD Serono, Inc. NDA Current 44087-9005 GONAL-F RFF follitropin alfa EMD Serono, Inc. BLA Current 44087-9005 GONAL-F RFF follitropin alfa EMD Serono, Inc. NDA Current 44087-9005 GONAL-F RFF follitropin alfa EMD Serono, Inc. BLA Current 50090-6049 GONAL-F RFF follitropin alfa A-S Medication Solutions BLA Current