Documents
Application Sponsors
| BLA 125504 | NOVARTIS PHARMS CORP | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 150MG/ML | 2 | COSENTYX | SECUKINUMAB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2015-01-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2016-01-15 | |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2018-06-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2018-01-23 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2017-09-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 31 | AP | 2020-01-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 35 | AP | 2020-06-16 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 43 | AP | 2021-05-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 50 | AP | 2021-12-22 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 51 | AP | 2021-12-22 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 43 | Null | 6 |
| SUPPL | 50 | Null | 7 |
| SUPPL | 51 | Null | 7 |
TE Codes
CDER Filings
NOVARTIS PHARMS CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 125504
[companyName] => NOVARTIS PHARMS CORP
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/125504s035lbl.pdf#page=22"]
[products] => [{"drugName":"COSENTYX","activeIngredients":"SECUKINUMAB","strength":"150MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
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[actionDate] => 2020-06-16
)
)