FDA.reportPublic FDA data

Application 021149

Type
BLA
Sponsor
EMD SERONO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021149Ovidrelchoriogonadotropin alfa351(a)Disc2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OVIDRELCHORIOGONADOTROPIN ALFAINJECTABLE;INJECTION0.25MG/VIALNoNo
002OVIDRELCHORIOGONADOTROPIN ALFAINJECTABLE;SUBCUTANEOUSEQ 0.25MG /0.5MLNoNo

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
OvidrelCHORIOGONADOTROPIN ALFAEMD Serono, Inc.a683e58a-63ea-44b8-a326-1a99a537bcf22023-12-26Warnings, Adverse reactionsExact identifier
application number: BLA021149
ndc (product): 44087-1150

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44087-1150Ovidrelchoriogonadotropin alfaEMD Serono, Inc.NDACurrent
44087-1150Ovidrelchoriogonadotropin alfaEMD Serono, Inc.BLACurrent
44087-1150Ovidrelchoriogonadotropin alfaEMD Serono, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62244APPL2020-03-23
41985ORIG2020-03-23
26908SUPPL2020-03-23
26907SUPPL2020-03-23
14504SUPPL2020-03-23
14503SUPPL2020-03-23
14502ORIG2020-03-23
4472SUPPL2020-03-23
4471ORIG2020-03-23