FDA.reportPublic FDA data

Application 017016

Type
BLA
Sponsor
FERRING

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
017016Novarelchorionic gonadotropin351(a)Disc2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
004CHORIONIC GONADOTROPINGONADOTROPIN, CHORIONICINJECTABLE;INJECTION20,000 UNITS/VIALNoNo
006CHORIONIC GONADOTROPINGONADOTROPIN, CHORIONICINJECTABLE;INJECTION5,000 UNITS/VIALNoNo
007CHORIONIC GONADOTROPINGONADOTROPIN, CHORIONICINJECTABLE;INJECTION10,000 UNITS/VIALNoNo
009CHORIONIC GONADOTROPINGONADOTROPIN, CHORIONICINJECTABLE;INJECTION2,000 UNITS/VIALNoNo
010CHORIONIC GONADOTROPINGONADOTROPIN, CHORIONICINJECTABLE;INJECTION15,000 UNITS/VIALNoNo
011CHORIONIC GONADOTROPINGONADOTROPIN, CHORIONICINJECTABLE;INJECTION2,000 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NovarelGONADOTROPHIN, CHORIONICFerring Pharmaceuticals Inc.ac6918ff-9dc3-40d9-8619-54b26e4bdfc82025-08-27Warnings, Adverse reactionsExact identifier
application number: BLA017016
ndc (product): 55566-1502

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55566-1501Novarelgonadotrophin, chorionicFerring Pharmaceuticals Inc.BLACurrent
55566-1501NovarelGonadotrophin, ChorionicFerring Pharmaceuticals Inc.NDACurrent
55566-1501Novarelgonadotrophin, chorionicFerring Pharmaceuticals Inc.BLACurrent
55566-1501Novarelgonadotrophin, chorionicFerring Pharmaceuticals Inc.NDACurrent
55566-1501Novarelgonadotrophin, chorionicFerring Pharmaceuticals Inc.BLACurrent
55566-1502Novarelgonadotrophin, chorionicFerring Pharmaceuticals Inc.BLACurrent
55566-1502NovarelGonadotrophin, ChorionicFerring Pharmaceuticals Inc.NDACurrent
55566-1502Novarelgonadotrophin, chorionicFerring Pharmaceuticals Inc.BLACurrent
55566-1502Novarelgonadotrophin, chorionicFerring Pharmaceuticals Inc.NDACurrent
55566-1502Novarelgonadotrophin, chorionicFerring Pharmaceuticals Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74360SUPPL 2023-05-24
62253APPL2020-03-23
33215SUPPL2020-03-23
527SUPPL2020-03-23