Home Applications 021149 Application 021149
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 021149 Ovidrel choriogonadotropin alfa 351(a) Disc 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OVIDREL CHORIOGONADOTROPIN ALFA INJECTABLE;INJECTION 0.25MG/VIAL No No 002 OVIDREL CHORIOGONADOTROPIN ALFA INJECTABLE;SUBCUTANEOUS EQ 0.25MG /0.5ML 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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 44087-1150 Ovidrel choriogonadotropin alfa EMD Serono, Inc. NDA Current 44087-1150 Ovidrel choriogonadotropin alfa EMD Serono, Inc. BLA Current 44087-1150 Ovidrel choriogonadotropin alfa EMD Serono, Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 62244 APPL 2020-03-23 41985 ORIG 2020-03-23 26908 SUPPL 2020-03-23 26907 SUPPL 2020-03-23 14504 SUPPL 2020-03-23 14503 SUPPL 2020-03-23 14502 ORIG 2020-03-23 4472 SUPPL 2020-03-23 4471 ORIG 2020-03-23