Home Applications 017692 Application 017692
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 017692 Pregnyl chorionic gonadotropin 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PREGNYL GONADOTROPIN, CHORIONIC INJECTABLE;INJECTION 10,000 UNITS/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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0052-0315 Pregnyl CHORIOGONADOTROPIN ALFA Organon USA Inc. BLA Current 0052-0315 Pregnyl CHORIOGONADOTROPIN ALFA Merck Sharp & Dohme LLC BLA Current 0052-0315 Pregnyl CHORIOGONADOTROPIN ALFA Organon USA Inc. NDA Current 0052-0315 Pregnyl CHORIOGONADOTROPIN ALFA Organon USA Inc. NDA Current 50090-5923 Pregnyl CHORIOGONADOTROPIN ALFA A-S Medication Solutions BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 73706 SUPPL 2023-03-08 73705 SUPPL 2023-03-08 73704 SUPPL 2023-03-08 73661 SUPPL 2023-03-03 73660 SUPPL 2023-03-03 73659 SUPPL 2023-03-03 62216 APPL 2020-03-23 33335 SUPPL 2020-03-23 33334 SUPPL 2020-03-23 13881 SUPPL 2020-03-23 687 SUPPL 2020-03-23 686 SUPPL 2020-03-23