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)Disc2026-06-01

Application Products#

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

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 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SerostimSOMATROPINEMD Serono, Inc.62b01d29-90f0-45b2-a0c4-3a750ba36c8a2026-07-28Warnings, Adverse reactionsName fallback
generic name: SOMATROPIN
GENOTROPINSOMATROPINPfizer Laboratories Div Pfizer Incffebf88b-d257-4542-9808-74d9b71677652026-04-30Warnings, Adverse reactionsName fallback
generic name: SOMATROPIN
HUMATROPESOMATROPINEli Lilly and Companya774e1ae-3997-49ee-8b0e-99a2b315d4092025-11-25Warnings, Adverse reactionsName fallback
generic name: SOMATROPIN
ZOMACTONSOMATROPINFerring Pharmaceuticals Inc.85ba081b-bee0-4a9a-aa0f-ae5b5e9a08862025-11-14Warnings, 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

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