Application 103471
- Type
- BLA
- Sponsor
- BAYER HEALTHCARE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BETASERON | INTERFERON BETA-1B | VIAL; SUBCUTANEOUS | 0.3 MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50419-524 | Betaseron | interferon beta-1b | Bayer HealthCare Pharmaceuticals Inc. | BLA | Current |
| 50419-524 | Betaseron | interferon beta-1b | Bayer HealthCare Pharmaceuticals Inc. | BLA | Current |
| 50419-524 | Betaseron | interferon beta-1b | Bayer HealthCare Pharmaceuticals Inc. | BLA | Current |
| 50419-524 | Betaseron | interferon beta-1b | Bayer HealthCare Pharmaceuticals Inc. | BLA | Current |
| 50419-524 | Betaseron | interferon beta-1b | Bayer HealthCare Pharmaceuticals Inc. | BLA | Current |
| 50419-524 | Betaseron | interferon beta-1b | Bayer HealthCare Pharmaceuticals Inc. | BLA | Current |
| 50419-524 | Betaseron | interferon beta-1b | Bayer HealthCare Pharmaceuticals Inc. | BLA | Current |
| 50419-524 | Betaseron | interferon beta-1b | Bayer HealthCare Pharmaceuticals Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78446 | SUPPL | 2024-05-10 |
| 74947 | SUPPL | 2023-07-31 |
| 74932 | SUPPL | 2023-07-31 |
| 74931 | SUPPL | 2023-07-31 |
| 72037 | SUPPL | 2022-09-07 |
| 72015 | SUPPL | 2022-09-06 |
| 69250 | SUPPL | 2021-11-05 |
| 69249 | SUPPL | 2021-11-05 |
| 69232 | SUPPL | 2021-11-05 |
| 66794 | SUPPL | 2021-03-17 |
| 64865 | SUPPL | 2020-10-07 |
| 64804 | SUPPL | 2020-10-02 |
| 62275 | SUPPL | 2020-03-24 |
| 62274 | SUPPL | 2020-03-24 |
| 59781 | SUPPL | 2019-08-20 |
| 59745 | SUPPL | 2019-08-20 |
| 55466 | SUPPL | 2018-09-13 |
| 55379 | SUPPL | 2018-09-04 |
| 55378 | SUPPL | 2018-09-04 |
| 54592 | SUPPL | 2018-06-14 |
| 48605 | SUPPL | 2017-05-31 |
| 39657 | SUPPL | 2016-04-27 |
| 31593 | SUPPL | 2016-04-22 |
| 39658 | SUPPL | 2015-12-28 |
| 9394 | SUPPL | 2015-12-23 |
| 39656 | SUPPL | 2015-10-07 |
| 9393 | SUPPL | 2015-09-28 |
| 18586 | SUPPL | 2014-01-31 |
| 31592 | SUPPL | 2014-01-29 |
| 18585 | SUPPL | 2013-07-11 |
| 31590 | SUPPL | 2013-07-02 |
| 39655 | SUPPL | 2012-12-13 |
| 39654 | SUPPL | 2012-12-13 |
| 39653 | SUPPL | 2012-12-13 |
| 39652 | SUPPL | 2012-12-13 |
| 39651 | SUPPL | 2012-12-13 |
| 31591 | SUPPL | 2012-12-13 |
| 31589 | SUPPL | 2012-12-13 |
| 31588 | SUPPL | 2012-12-13 |
| 31587 | SUPPL | 2012-12-13 |
| 31586 | SUPPL | 2012-12-13 |
| 18584 | SUPPL | 2012-12-13 |
| 18583 | SUPPL | 2012-12-13 |
| 18582 | SUPPL | 2012-12-13 |
| 9392 | SUPPL | 2012-12-13 |
| 9391 | SUPPL | 2012-12-13 |
| 9390 | SUPPL | 2012-12-13 |
| 39650 | SUPPL | 2008-04-21 |
| 22735 | ORIG | 2007-06-11 |
| 22736 | SUPPL | 2004-03-11 |
| 18581 | SUPPL | 2004-03-11 |
| 9388 | SUPPL | 2004-03-11 |
| 9389 | SUPPL | 2003-10-31 |