FDA.reportPublic FDA data

Application 019640

Type
BLA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HUMATROPESOMATROPININJECTABLE;INJECTION2MG/VIALNoNo
004HUMATROPESOMATROPININJECTABLE;INJECTION5MG/VIALNoNo
005HUMATROPESOMATROPININJECTABLE;INJECTION6MG/VIALNoNo
006HUMATROPESOMATROPININJECTABLE;INJECTION12MG/VIALNoNo
007HUMATROPESOMATROPININJECTABLE;INJECTION24MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-7335HUMATROPESomatropinEli Lilly and CompanyBLACurrent
0002-7335HUMATROPESomatropinEli Lilly and CompanyNDACurrent
0002-7335HUMATROPESomatropinEli Lilly and CompanyNDACurrent
0002-7335HUMATROPESomatropinEli Lilly and CompanyNDACurrent
0002-7335HUMATROPESomatropinEli Lilly and CompanyBLACurrent
0002-7335HUMATROPESomatropinEli Lilly and CompanyBLACurrent
0002-8147HUMATROPESomatropinEli Lilly and CompanyBLACurrent
0002-8147HUMATROPESomatropinEli Lilly and CompanyBLACurrent
0002-8147HUMATROPESomatropinEli Lilly and CompanyNDACurrent
0002-8147HUMATROPESomatropinEli Lilly and CompanyNDACurrent
0002-8147HUMATROPESomatropinEli Lilly and CompanyBLACurrent
0002-8147HUMATROPESomatropinEli Lilly and CompanyNDACurrent
0002-8147HUMATROPESomatropinEli Lilly and CompanyBLACurrent
0002-8148HUMATROPESomatropinEli Lilly and CompanyNDACurrent
0002-8148HUMATROPESomatropinEli Lilly and CompanyNDACurrent
0002-8148HUMATROPESomatropinEli Lilly and CompanyNDACurrent
0002-8148HUMATROPESomatropinEli Lilly and CompanyBLACurrent
0002-8148HUMATROPESomatropinEli Lilly and CompanyBLACurrent
0002-8148HUMATROPESomatropinEli Lilly and CompanyBLACurrent
0002-8148HUMATROPESomatropinEli Lilly and CompanyBLACurrent
0002-8149HUMATROPESomatropinEli Lilly and CompanyNDACurrent
0002-8149HUMATROPESomatropinEli Lilly and CompanyNDACurrent
0002-8149HUMATROPESomatropinEli Lilly and CompanyNDACurrent
0002-8149HUMATROPESomatropinEli Lilly and CompanyBLACurrent
0002-8149HUMATROPESomatropinEli Lilly and CompanyBLACurrent
0002-8149HUMATROPESomatropinEli Lilly and CompanyBLACurrent
0002-8149HUMATROPESomatropinEli Lilly and CompanyBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84338SUPPL 2025-11-28
84324SUPPL 2025-11-28
82810SUPPL 2025-07-11
82769SUPPL 2025-07-11
76763SUPPL 2023-12-11
76755SUPPL 2023-12-11
66424SUPPL2021-03-01
66404APPL2020-03-23
60709SUPPL2020-03-23
60708SUPPL2020-03-23
60703SUPPL2020-03-23
60702SUPPL2020-03-23
46183SUPPL2020-03-23
46149SUPPL2020-03-23
40944SUPPL2020-03-23
40943SUPPL2020-03-23
40942SUPPL2020-03-23
33822SUPPL2020-03-23
33821SUPPL2020-03-23
33820SUPPL2020-03-23
33819SUPPL2020-03-23
20272SUPPL2020-03-23
20271SUPPL2020-03-23
20270SUPPL2020-03-23
17500SUPPL2020-03-23
17499SUPPL2020-03-23
17498SUPPL2020-03-23
17497SUPPL2020-03-23
11581SUPPL2020-03-23
11580SUPPL2020-03-23
11579SUPPL2020-03-23
11578SUPPL2020-03-23
11577SUPPL2020-03-23
11576SUPPL2020-03-23
11575SUPPL2020-03-23
1439SUPPL2020-03-23
1438SUPPL2020-03-23
1437SUPPL2020-03-23
1436SUPPL2020-03-23
1435SUPPL2020-03-23
1434SUPPL2020-03-23
1433SUPPL2020-03-23
1432SUPPL2020-03-23
1431SUPPL2020-03-23
1430SUPPL2020-03-23
1429SUPPL2020-03-23
1428SUPPL2020-03-23