FDA.reportPublic FDA data

Application 019764

Type
BLA
Sponsor
EMD SERONO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
019764Saizensomatropin351(a)Disc2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SAIZENSOMATROPININJECTABLE;INJECTION6MG/VIALNoNo
002SAIZENSOMATROPININJECTABLE;INJECTION5MG/VIALNoNo
003SAIZENSOMATROPININJECTABLE;INJECTION8.8MG/VIALNoNo
005SAIZENSOMATROPININJECTABLE;INJECTION4MG/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 · 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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44087-0016saizenprepsomatropinEMD Serono, Inc.BLACurrent
44087-0016saizenprepsomatropinEMD Serono, Inc.NDACurrent
44087-0016saizenprepsomatropinEMD Serono, Inc.NDACurrent
44087-0016saizenprepsomatropinEMD Serono, Inc.BLACurrent
44087-1005SaizensomatropinEMD Serono, Inc.BLACurrent
44087-1005SaizensomatropinEMD Serono, Inc.NDACurrent
44087-1005SaizensomatropinEMD Serono, Inc.NDACurrent
44087-1005SaizensomatropinEMD Serono, Inc.BLACurrent
44087-1080SAIZEN CLICKEASYsomatropinEMD Serono, Inc.NDACurrent
44087-1088SaizensomatropinEMD Serono, Inc.BLACurrent
44087-1088SaizensomatropinEMD Serono, Inc.NDACurrent
44087-1088SaizensomatropinEMD Serono, Inc.NDACurrent
44087-1088SaizensomatropinEMD Serono, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66500SUPPL2021-03-05
48339SUPPL2020-03-23
48320SUPPL2020-03-23
47288SUPPL2020-03-23
46883SUPPL2020-03-23
46188SUPPL2020-03-23
46152SUPPL2020-03-23
33921SUPPL2020-03-23
33920SUPPL2020-03-23
33919SUPPL2020-03-23
33918SUPPL2020-03-23
33917SUPPL2020-03-23
20315SUPPL2020-03-23
19161SUPPL2020-03-23
19160SUPPL2020-03-23
19159SUPPL2020-03-23
19158SUPPL2020-03-23
19157SUPPL2020-03-23
19156SUPPL2020-03-23
11682SUPPL2020-03-23
11681SUPPL2020-03-23
11680SUPPL2020-03-23
11679SUPPL2020-03-23
11678SUPPL2020-03-23
1580SUPPL2020-03-23
1579SUPPL2020-03-23
1578SUPPL2020-03-23
1577SUPPL2020-03-23
66422APPL