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)Disc2026-09-01

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#

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 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

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