FDA.reportPublic FDA data

Application 020522

Type
BLA
Sponsor
GENENTECH

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020522Nutropin AQsomatropin351(a)Disc2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NUTROPIN AQSOMATROPININJECTABLE;INJECTION10MG/2ML (5MG/ML)NoNo
002NUTROPIN AQ PENSOMATROPININJECTABLE;INJECTION10MG/2ML (5MG/ML)NoNo
003NUTROPIN AQ NUSPINSOMATROPININJECTABLE;INJECTION5MG/2ML (2.5MG/ML)NoNo
004NUTROPIN AQ NUSPINSOMATROPININJECTABLE;INJECTION20MG/2ML (10MG/ML)NoNo
005NUTROPIN AQ NUSPINSOMATROPININJECTABLE;INJECTION10MG/2ML (5MG/ML)NoNo
006NUTROPIN AQ PENSOMATROPININJECTABLE;INJECTION20MG/2ML (10MG/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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GENOTROPINSOMATROPINPfizer Laboratories Div Pfizer Incffebf88b-d257-4542-9808-74d9b71677652026-08-04Warnings, Adverse reactionsName fallback
generic name: SOMATROPIN
SerostimSOMATROPINEMD Serono, Inc.62b01d29-90f0-45b2-a0c4-3a750ba36c8a2026-07-28Warnings, 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 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-074Nutropin AQ NuSpin 10somatropinGenentech, Inc.BLACurrent
50242-074Nutropin AQ NuSpin 10somatropinGenentech, Inc.NDACurrent
50242-074Nutropin AQ NuSpin 10somatropinGenentech, Inc.BLACurrent
50242-074Nutropin AQ NuSpin 10somatropinGenentech, Inc.BLACurrent
50242-074Nutropin AQ NuSpin 10somatropinGenentech, Inc.BLACurrent
50242-074Nutropin AQ NuSpin 10somatropinGenentech, Inc.NDACurrent
50242-074Nutropin AQ NuSpin 10somatropinGenentech, Inc.BLACurrent
50242-075Nutropin AQ NuSpin 5somatropinGenentech, Inc.BLACurrent
50242-075Nutropin AQ NuSpin 5somatropinGenentech, Inc.NDACurrent
50242-075Nutropin AQ NuSpin 5somatropinGenentech, Inc.BLACurrent
50242-075Nutropin AQ NuSpin 5somatropinGenentech, Inc.BLACurrent
50242-075Nutropin AQ NuSpin 5somatropinGenentech, Inc.BLACurrent
50242-075Nutropin AQ NuSpin 5somatropinGenentech, Inc.NDACurrent
50242-075Nutropin AQ NuSpin 5somatropinGenentech, Inc.BLACurrent
50242-076Nutropin AQ NuSpin 20somatropinGenentech, Inc.BLACurrent
50242-076Nutropin AQ NuSpin 20somatropinGenentech, Inc.NDACurrent
50242-076Nutropin AQ NuSpin 20somatropinGenentech, Inc.BLACurrent
50242-076Nutropin AQ NuSpin 20somatropinGenentech, Inc.BLACurrent
50242-076Nutropin AQ NuSpin 20somatropinGenentech, Inc.BLACurrent
50242-076Nutropin AQ NuSpin 20somatropinGenentech, Inc.NDACurrent
50242-076Nutropin AQ NuSpin 20somatropinGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82797SUPPL 2025-07-11
82773SUPPL 2025-07-11
66475SUPPL2021-03-03
46180SUPPL2020-03-23
46158SUPPL2020-03-23
44450SUPPL2020-03-23
44449SUPPL2020-03-23
41412SUPPL2020-03-23
41411SUPPL2020-03-23
41410SUPPL2020-03-23
34768SUPPL2020-03-23
34767SUPPL2020-03-23
34766SUPPL2020-03-23
34765SUPPL2020-03-23
34764SUPPL2020-03-23
34763SUPPL2020-03-23
34762SUPPL2020-03-23
25112SUPPL2020-03-23
25111SUPPL2020-03-23
25110SUPPL2020-03-23
25109SUPPL2020-03-23
25108SUPPL2020-03-23
25107SUPPL2020-03-23
25106SUPPL2020-03-23
25105SUPPL2020-03-23
23972SUPPL2020-03-23
23971SUPPL2020-03-23
20701SUPPL2020-03-23
20700SUPPL2020-03-23
12680SUPPL2020-03-23
12679SUPPL2020-03-23
12678SUPPL2020-03-23
12677SUPPL2020-03-23
2662SUPPL2020-03-23
2661SUPPL2020-03-23
2660SUPPL2020-03-23
2659SUPPL2020-03-23
66420APPL2020-03-22