FDA.reportPublic FDA data

Application 021148

Type
BLA
Sponsor
NOVO NORDISK INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021148Norditropinsomatropin351(a)Disc2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORDITROPINSOMATROPININJECTABLE;INJECTION5MG/1.5MLNoNo
002NORDITROPINSOMATROPININJECTABLE;INJECTION10MG/1.5MLNoNo
003NORDITROPINSOMATROPININJECTABLE;INJECTION15MG/1.5MLNoNo
004NORDITROPIN NORDIFLEXSOMATROPININJECTABLE;INJECTION5MG/1.5MLNoNo
005NORDITROPIN NORDIFLEXSOMATROPININJECTABLE;INJECTION10MG/1.5MLNoNo
006NORDITROPIN NORDIFLEXSOMATROPININJECTABLE;INJECTION15MG/1.5MLNoNo
007NORDITROPIN NORDIFLEXSOMATROPININJECTABLE;INJECTION30MG/3MLNoNo
008NORDITROPIN FLEXPROSOMATROPININJECTABLE;INJECTION5MG/1.5MLNoNo
009NORDITROPIN FLEXPROSOMATROPININJECTABLE;INJECTION10MG/1.5MLNoNo
010NORDITROPIN FLEXPROSOMATROPININJECTABLE;INJECTION15MG/1.5MLNoNo
011NORDITROPIN FLEXPROSOMATROPININJECTABLE;INJECTION30MG/3MLNoNo

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NorditropinSOMATROPINNovo Nordisk1058e17c-9261-459c-a3e6-fae38d196c142025-07-07Warnings, Adverse reactionsExact identifier
application number: BLA021148
ndc (product): 0169-7705
ndc (product): 0169-7703
ndc (product): 0169-7708
ndc (product): 0169-7704

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-7703NorditropinsomatropinNovo NordiskNDACurrent
0169-7703NorditropinsomatropinNovo NordiskBLACurrent
0169-7703NorditropinsomatropinNovo NordiskNDACurrent
0169-7703NorditropinsomatropinNovo NordiskNDACurrent
0169-7703NorditropinsomatropinNovo NordiskBLACurrent
0169-7704NorditropinsomatropinNovo NordiskNDACurrent
0169-7704NorditropinsomatropinNovo NordiskBLACurrent
0169-7704NorditropinsomatropinNovo NordiskNDACurrent
0169-7704NorditropinsomatropinNovo NordiskNDACurrent
0169-7704NorditropinsomatropinNovo NordiskBLACurrent
0169-7705NorditropinsomatropinNovo NordiskNDACurrent
0169-7705NorditropinsomatropinNovo NordiskBLACurrent
0169-7705NorditropinsomatropinNovo NordiskNDACurrent
0169-7705NorditropinsomatropinNovo NordiskNDACurrent
0169-7705NorditropinsomatropinNovo NordiskBLACurrent
0169-7708NorditropinsomatropinNovo NordiskNDACurrent
0169-7708NorditropinsomatropinNovo NordiskBLACurrent
0169-7708NorditropinsomatropinNovo NordiskNDACurrent
0169-7708NorditropinsomatropinNovo NordiskNDACurrent
0169-7708NorditropinsomatropinNovo NordiskBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82799SUPPL 2025-07-11
82774SUPPL 2025-07-11
81078SUPPL 2025-02-06
81077SUPPL 2025-02-06
81065SUPPL 2025-02-06
81064SUPPL 2025-02-06
66456SUPPL2021-03-02
66439ORIG2021-03-02
66405APPL2020-03-23
62106SUPPL2020-03-23
62097SUPPL2020-03-23
52721SUPPL2020-03-23
52720SUPPL2020-03-23
52713SUPPL2020-03-23
52712SUPPL2020-03-23
49635SUPPL2020-03-23
49619SUPPL2020-03-23
46184SUPPL2020-03-23
46157SUPPL2020-03-23
36219SUPPL2020-03-23
36218SUPPL2020-03-23
36217SUPPL2020-03-23
36216SUPPL2020-03-23
36215SUPPL2020-03-23
36214SUPPL2020-03-23
36213SUPPL2020-03-23
36212SUPPL2020-03-23
36211ORIG2020-03-23
26906SUPPL2020-03-23
26905SUPPL2020-03-23
26904SUPPL2020-03-23
26903SUPPL2020-03-23
26902SUPPL2020-03-23
26901SUPPL2020-03-23
26900SUPPL2020-03-23
21477ORIG2020-03-23
14501SUPPL2020-03-23
14500SUPPL2020-03-23
14499SUPPL2020-03-23
14498SUPPL2020-03-23
14497SUPPL2020-03-23
14496SUPPL2020-03-23
4470SUPPL2020-03-23
4469SUPPL2020-03-23
4468SUPPL2020-03-23
4467SUPPL2020-03-23
4466SUPPL2020-03-23
4465SUPPL2020-03-23
4464SUPPL2020-03-23
4463SUPPL2020-03-23
4462SUPPL2020-03-23
4461SUPPL2020-03-23
4460ORIG2020-03-23