Application 125290
- Type
- BLA
- Sponsor
- NOVARTIS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EXTAVIA | INTERFERON BETA-1B | INJECTABLE; SUBCUTANEOUS | 0.0625MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0569 | EXTAVIA | Interferon beta-1b | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0569 | EXTAVIA | Interferon beta-1b | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0569 | EXTAVIA | Interferon beta-1b | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0569 | EXTAVIA | Interferon beta-1b | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0569 | EXTAVIA | Interferon beta-1b | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0569 | EXTAVIA | Interferon beta-1b | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0569 | EXTAVIA | Interferon beta-1b | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0569 | EXTAVIA | Interferon beta-1b | Novartis Pharmaceuticals Corporation | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69248 | SUPPL | 2021-11-05 |
| 69247 | SUPPL | 2021-11-05 |
| 69229 | SUPPL | 2021-11-05 |
| 64872 | SUPPL | 2020-10-07 |
| 64871 | SUPPL | 2020-10-07 |
| 64820 | SUPPL | 2020-10-05 |
| 59780 | SUPPL | 2019-08-20 |
| 59779 | SUPPL | 2019-08-20 |
| 59744 | SUPPL | 2019-08-20 |
| 56859 | SUPPL | 2018-12-20 |
| 56709 | SUPPL | 2018-12-12 |
| 39908 | SUPPL | 2016-05-17 |
| 9685 | SUPPL | 2016-05-16 |
| 18853 | SUPPL | 2015-12-28 |
| 9686 | SUPPL | 2015-12-23 |
| 31908 | SUPPL | 2014-12-30 |
| 31909 | SUPPL | 2012-03-20 |
| 44798 | ORIG | 2010-04-22 |
| 43316 | ORIG | 2010-04-22 |
| 31907 | ORIG | 2009-08-25 |
| 39907 | ORIG | 2009-08-20 |