FDA.reportPublic FDA data

Application 020604

Type
BLA
Sponsor
EMD SERONO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020604Serostimsomatropin351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SEROSTIMSOMATROPININJECTABLE;INJECTION6MG/VIALNoNo
002SEROSTIMSOMATROPININJECTABLE;INJECTION5MG/VIALNoNo
003SEROSTIMSOMATROPININJECTABLE;INJECTION4MG/VIALNoNo
004SEROSTIMSOMATROPININJECTABLE;INJECTION8.8MG/VIALNoNo
005SEROSTIM LQSOMATROPININJECTABLE;SUBCUTANEOUS6MG/0.5ML (6MG/0.5ML)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 · 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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44087-0004SerostimsomatropinEMD Serono, Inc.NDACurrent
44087-0004SerostimsomatropinEMD Serono, Inc.BLACurrent
44087-0004SerostimsomatropinEMD Serono, Inc.NDACurrent
44087-0004SerostimsomatropinEMD Serono, Inc.BLACurrent
44087-0005SerostimsomatropinEMD Serono, Inc.NDACurrent
44087-0005SerostimsomatropinEMD Serono, Inc.BLACurrent
44087-0005SerostimsomatropinEMD Serono, Inc.NDACurrent
44087-0005SerostimsomatropinEMD Serono, Inc.BLACurrent
44087-0006SerostimsomatropinEMD Serono, Inc.NDACurrent
44087-0006SerostimsomatropinEMD Serono, Inc.BLACurrent
44087-0006SerostimsomatropinEMD Serono, Inc.NDACurrent
44087-0006SerostimsomatropinEMD Serono, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66561SUPPL2021-03-05
48547SUPPL2020-03-23
48526SUPPL2020-03-23
48361SUPPL2020-03-23
48336SUPPL2020-03-23
46200SUPPL2020-03-23
46187SUPPL2020-03-23
46156SUPPL2020-03-23
46155SUPPL2020-03-23
41475SUPPL2020-03-23
41474SUPPL2020-03-23
41473SUPPL2020-03-23
34948SUPPL2020-03-23
34947SUPPL2020-03-23
34946SUPPL2020-03-23
34945SUPPL2020-03-23
34944SUPPL2020-03-23
34943SUPPL2020-03-23
25305SUPPL2020-03-23
25304SUPPL2020-03-23
25303SUPPL2020-03-23
25302SUPPL2020-03-23
25301SUPPL2020-03-23
25300SUPPL2020-03-23
20760SUPPL2020-03-23
12829SUPPL2020-03-23
12828SUPPL2020-03-23
12827SUPPL2020-03-23
12826SUPPL2020-03-23
12825SUPPL2020-03-23
12824SUPPL2020-03-23
2859SUPPL2020-03-23
2858SUPPL2020-03-23
2857SUPPL2020-03-23
2856SUPPL2020-03-23
2855SUPPL2020-03-23
2854SUPPL2020-03-23
2853SUPPL2020-03-23
66423APPL2020-03-22