Home Applications 021211 Application 021211
Type BLA
Sponsor ORGANON USA INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 021211 Follistim AQ Cartridge follitropin beta 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FOLLISTIM AQ FOLLITROPIN ALFA/BETA INJECTABLE;SUBCUTANEOUS 300 IU/0.36ML No No 002 FOLLISTIM AQ FOLLITROPIN ALFA/BETA INJECTABLE;SUBCUTANEOUS 600 IU/0.72ML No No 003 FOLLISTIM AQ FOLLITROPIN ALFA/BETA INJECTABLE;SUBCUTANEOUS 150 IU/0.18ML No No 004 FOLLISTIM AQ FOLLITROPIN ALFA/BETA INJECTABLE;SUBCUTANEOUS 900 IU/1.08ML 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 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0052-0313 Follistim AQ follitropin Merck Sharp & Dohme LLC BLA Current 0052-0313 Follistim AQ follitropin Organon USA Inc. BLA Current 0052-0313 Follistim AQ follitropin Organon USA Inc. NDA Current 0052-0313 Follistim AQ follitropin Organon USA Inc. NDA Current 0052-0313 Follistim AQ follitropin Organon USA Inc. BLA Current 0052-0313 Follistim AQ follitropin Organon USA Inc. BLA Current 0052-0316 Follistim AQ follitropin Merck Sharp & Dohme LLC BLA Current 0052-0316 Follistim AQ follitropin Organon USA Inc. BLA Current 0052-0316 Follistim AQ follitropin Organon USA Inc. NDA Current 0052-0316 Follistim AQ follitropin Organon USA Inc. NDA Current 0052-0316 Follistim AQ follitropin Organon USA Inc. BLA Current 0052-0316 Follistim AQ follitropin Organon USA Inc. BLA Current 0052-0326 Follistim AQ follitropin Merck Sharp & Dohme LLC BLA Current 0052-0326 Follistim AQ follitropin Organon USA Inc. BLA Current 0052-0326 Follistim AQ follitropin Organon USA Inc. NDA Current 0052-0326 Follistim AQ follitropin Organon USA Inc. NDA Current 0052-0326 Follistim AQ follitropin Organon USA Inc. BLA Current 0052-0326 Follistim AQ follitropin Organon USA Inc. BLA Current