FDA.reportPublic FDA data

Application 021148

Type
BLA
Sponsor
NOVO NORDISK INC

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

NDC Listings For This Application#

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

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