FDA.reportPublic FDA data

Application 021538

Type
BLA
Sponsor
EMERGENT

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021538Accretropinsomatropin351(a)Disc2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACCRETROPINSOMATROPININJECTABLE;INJECTION5MG/ML (5MG/ML)NoNo

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 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HUMATROPESOMATROPINEli Lilly and Companya774e1ae-3997-49ee-8b0e-99a2b315d4092026-08-20Warnings, Adverse reactionsName fallback
generic name: SOMATROPIN
GENOTROPINSOMATROPINPfizer Laboratories Div Pfizer Incffebf88b-d257-4542-9808-74d9b71677652026-08-04Warnings, Adverse reactionsName fallback
generic name: SOMATROPIN
ZOMACTONSOMATROPINFerring Pharmaceuticals Inc.85ba081b-bee0-4a9a-aa0f-ae5b5e9a08862026-04-20Warnings, Adverse reactionsName fallback
generic name: SOMATROPIN
OmnitropeSOMATROPINSandoz Inc58d84ffa-4056-4e36-ad67-7bd4aef444a52025-07-10Warnings, Adverse reactionsName fallback
generic name: SOMATROPIN
NorditropinSOMATROPINNovo Nordisk1058e17c-9261-459c-a3e6-fae38d196c142025-07-07Warnings, Adverse reactionsName fallback
generic name: SOMATROPIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66333ORIG2021-02-23
66403APPL2020-03-23
53409ORIG2020-03-23
53408ORIG2020-03-23
53407ORIG2020-03-23
46182SUPPL2020-03-23
46160SUPPL2020-03-23
42204ORIG2020-03-23
37179ORIG2020-03-23
24204ORIG2020-03-23
5678ORIG2020-03-23
63558ORIG1900-01-01
63557ORIG1900-01-01
63556ORIG1900-01-01