FDA.reportPublic FDA data

Application 021426

Type
BLA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMNITROPESOMATROPININJECTABLE;INJECTION5.8MG/VIALNoNo
002OMNITROPESOMATROPININJECTABLE;INJECTION1.5MG/VIALNoNo
003OMNITROPESOMATROPININJECTABLE;INJECTION5MG/1.5MLNoNo
004OMNITROPESOMATROPININJECTABLE;INJECTION10MG/1.5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3001OmnitropeSomatropinSandoz IncBLACurrent
0781-3001OmnitropeSomatropinSandoz IncNDACurrent
0781-3001OmnitropeSomatropinSandoz IncNDACurrent
0781-3001OmnitropeSomatropinSandoz IncNDACurrent
0781-3004OmnitropeSomatropinSandoz IncBLACurrent
0781-3004OmnitropeSomatropinSandoz IncNDACurrent
0781-3004OmnitropeSomatropinSandoz IncNDACurrent
0781-3004OmnitropeSomatropinSandoz IncNDACurrent
0781-4004OmnitropeSomatropinSandoz IncBLACurrent
0781-4004OmnitropeSomatropinSandoz IncNDACurrent
0781-4004OmnitropeSomatropinSandoz IncNDACurrent
0781-4004OmnitropeSomatropinSandoz IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82784SUPPL 2025-07-11
82775SUPPL 2025-07-11
80206SUPPL 2024-11-13
80202SUPPL 2024-11-13
80201SUPPL 2024-11-13
69991SUPPL2022-01-28
66499ORIG2021-03-04
47256SUPPL2020-03-23
46185SUPPL2020-03-23
46159SUPPL2020-03-23
42149SUPPL2020-03-23
42148SUPPL2020-03-23
36880SUPPL2020-03-23
36879SUPPL2020-03-23
36878SUPPL2020-03-23
36877SUPPL2020-03-23
36876SUPPL2020-03-23
36875ORIG2020-03-23
27733SUPPL2020-03-23
27732SUPPL2020-03-23
27731SUPPL2020-03-23
27730SUPPL2020-03-23
27729SUPPL2020-03-23
27728ORIG2020-03-23
21648SUPPL2020-03-23
21647SUPPL2020-03-23
21646ORIG2020-03-23
15426SUPPL2020-03-23
15425SUPPL2020-03-23
15424SUPPL2020-03-23
15423SUPPL2020-03-23
5325SUPPL2020-03-23
5324SUPPL2020-03-23
5323SUPPL2020-03-23
5322SUPPL2020-03-23
66421APPL