Home Applications 017016 Application 017016
Type BLA
Sponsor FERRING Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 017016 Novarel chorionic gonadotropin 351(a) Disc 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 004 CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC INJECTABLE;INJECTION 20,000 UNITS/VIAL No No 006 CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC INJECTABLE;INJECTION 5,000 UNITS/VIAL No No 007 CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC INJECTABLE;INJECTION 10,000 UNITS/VIAL No No 009 CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC INJECTABLE;INJECTION 2,000 UNITS/VIAL No No 010 CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC INJECTABLE;INJECTION 15,000 UNITS/VIAL No No 011 CHORIONIC GONADOTROPIN GONADOTROPIN, CHORIONIC INJECTABLE;INJECTION 2,000 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Novarel GONADOTROPHIN, CHORIONIC Ferring Pharmaceuticals Inc. ac6918ff-9dc3-40d9-8619-54b26e4bdfc8 2025-08-27 Warnings, Adverse reactions Exact identifier application number: BLA017016 ndc (product): 55566-1502
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55566-1501 Novarel gonadotrophin, chorionic Ferring Pharmaceuticals Inc. BLA Current 55566-1501 Novarel Gonadotrophin, Chorionic Ferring Pharmaceuticals Inc. NDA Current 55566-1501 Novarel gonadotrophin, chorionic Ferring Pharmaceuticals Inc. BLA Current 55566-1501 Novarel gonadotrophin, chorionic Ferring Pharmaceuticals Inc. NDA Current 55566-1501 Novarel gonadotrophin, chorionic Ferring Pharmaceuticals Inc. BLA Current 55566-1502 Novarel gonadotrophin, chorionic Ferring Pharmaceuticals Inc. BLA Current 55566-1502 Novarel Gonadotrophin, Chorionic Ferring Pharmaceuticals Inc. NDA Current 55566-1502 Novarel gonadotrophin, chorionic Ferring Pharmaceuticals Inc. BLA Current 55566-1502 Novarel gonadotrophin, chorionic Ferring Pharmaceuticals Inc. NDA Current 55566-1502 Novarel gonadotrophin, chorionic Ferring Pharmaceuticals Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 74360 SUPPL 2023-05-24 62253 APPL 2020-03-23 33215 SUPPL 2020-03-23 527 SUPPL 2020-03-23