FDA.reportPublic FDA data

Application 017054

Type
BLA
Sponsor
BEL MAR

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
017054Chorionic Gonadotropinchorionic gonadotropin351(a)Disc2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHORIONIC GONADOTROPINGONADOTROPIN, CHORIONICINJECTABLE;INJECTION5,000 UNITS/VIALNoNo
002CHORIONIC GONADOTROPINGONADOTROPIN, CHORIONICINJECTABLE;INJECTION10,000 UNITS/VIALNoNo

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chorionic GonadotropinCHORIONIC GONADOTROPINFresenius Kabi USA, LLCf93b2baa-03ac-4650-b35a-20b818d712d62025-04-11Warnings, Adverse reactionsName fallback
brand name: Chorionic Gonadotropin
Chorionic GonadotropinCHORIONIC GONADOTROPINNuCare Pharmaceuticals,Inc.312ee87a-c6c3-6111-e063-6394a90ad8d72025-03-25Warnings, Adverse reactionsName fallback
brand name: Chorionic Gonadotropin

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62252APPL2020-03-23