Application 125387
- Type
- BLA
- Sponsor
- REGENERON PHARMACEUTICALS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EYLEA | AFLIBERCEPT | INJECTABLE; INJECTION | 40MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 61755-005 | EYLEA | aflibercept | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-005 | EYLEA | aflibercept | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-005 | EYLEA | aflibercept | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-005 | EYLEA | aflibercept | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-005 | EYLEA | aflibercept | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-005 | EYLEA | aflibercept | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-005 | EYLEA | aflibercept | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-005 | EYLEA | aflibercept | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-005 | EYLEA | aflibercept | Regeneron Pharmaceuticals, Inc. | BLA | Current |
| 61755-005 | EYLEA | aflibercept | Regeneron Pharmaceuticals, Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79870 | SUPPL | 2024-10-11 |
| 79862 | SUPPL | 2024-10-11 |
| 76855 | SUPPL | 2023-12-15 |
| 76846 | SUPPL | 2023-12-15 |
| 73431 | SUPPL | 2023-02-09 |
| 73421 | SUPPL | 2023-02-09 |
| 72038 | SUPPL | 2022-09-07 |
| 72019 | SUPPL | 2022-09-07 |
| 68760 | SUPPL | 2021-09-24 |
| 66955 | SUPPL | 2021-04-01 |
| 66929 | SUPPL | 2021-03-31 |
| 62856 | SUPPL | 2020-05-08 |
| 62277 | SUPPL | 2020-03-24 |
| 62276 | SUPPL | 2020-03-24 |
| 62199 | SUPPL | 2020-03-19 |
| 60563 | SUPPL | 2019-10-15 |
| 57215 | SUPPL | 2019-08-07 |
| 58724 | SUPPL | 2019-05-15 |
| 58663 | SUPPL | 2019-05-14 |
| 57212 | SUPPL | 2019-01-14 |
| 55223 | SUPPL | 2018-08-20 |
| 55222 | SUPPL | 2018-08-20 |
| 55194 | SUPPL | 2018-08-17 |
| 55193 | SUPPL | 2018-08-17 |
| 48600 | SUPPL | 2017-05-31 |
| 48576 | SUPPL | 2017-05-31 |
| 45723 | SUPPL | 2016-10-31 |
| 45648 | SUPPL | 2016-10-26 |
| 31950 | SUPPL | 2016-05-25 |
| 18898 | SUPPL | 2016-05-25 |
| 31949 | SUPPL | 2015-08-04 |
| 18896 | SUPPL | 2015-08-04 |
| 18897 | SUPPL | 2015-03-26 |
| 9735 | SUPPL | 2015-03-26 |
| 39947 | SUPPL | 2014-10-09 |
| 9734 | SUPPL | 2014-10-08 |
| 9733 | SUPPL | 2014-07-31 |
| 18895 | SUPPL | 2014-01-28 |
| 9732 | SUPPL | 2014-01-28 |
| 39946 | SUPPL | 2013-06-11 |
| 39945 | SUPPL | 2013-06-11 |
| 31948 | SUPPL | 2013-06-11 |
| 31947 | SUPPL | 2013-06-11 |
| 39944 | SUPPL | 2012-09-25 |
| 9731 | SUPPL | 2012-09-24 |
| 24366 | ORIG | 2012-01-10 |
| 22806 | ORIG | 2012-01-10 |
| 9730 | ORIG | 2011-11-22 |
| 39943 | ORIG | 2011-11-21 |