Documents
Application Sponsors
| BLA 125290 | NOVARTIS PHARMS | |
Marketing Status
Application Products
| 001 | INJECTABLE; SUBCUTANEOUS | 0.0625MG | 2 | EXTAVIA | INTERFERON BETA-1B |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2009-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2014-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2011-06-22 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2012-03-18 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2016-05-12 | STANDARD |
| LABELING; Labeling | SUPPL | 63 | AP | 2015-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 66 | AP | 2018-12-11 | STANDARD |
| LABELING; Labeling | SUPPL | 67 | AP | 2019-08-16 | STANDARD |
| LABELING; Labeling | SUPPL | 70 | AP | 2020-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 73 | AP | 2021-11-03 | STANDARD |
Submissions Property Types
| SUPPL | 29 | Null | 15 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 62 | Null | 15 |
| SUPPL | 63 | Null | 6 |
| SUPPL | 66 | Null | 33 |
| SUPPL | 67 | Null | 7 |
| SUPPL | 70 | Null | 6 |
| SUPPL | 73 | Null | 15 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 125290
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)