Application 125031
- Type
- BLA
- Sponsor
- AMGEN
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEULASTA | PEGFILGRASTIM | SYRINGE | 6MG/0.6ML | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55513-190 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-190 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-190 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-190 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-190 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-190 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-190 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-190 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-190 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-190 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-190 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-192 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-192 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-192 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-192 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-192 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-192 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-192 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-192 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-192 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-192 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
| 55513-192 | Neulasta | pegfilgrastim | Amgen Inc | BLA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 83286 | SUPPL | 2025-09-05 |
| 83285 | SUPPL | 2025-09-04 |
| 83283 | SUPPL | 2025-09-04 |
| 67004 | SUPPL | 2021-04-07 |
| 66094 | SUPPL | 2021-02-04 |
| 66085 | SUPPL | 2021-02-03 |
| 65835 | SUPPL | 2021-01-06 |
| 65823 | SUPPL | 2021-01-06 |
| 65292 | SUPPL | 2020-11-19 |
| 65276 | SUPPL | 2020-11-19 |
| 61531 | SUPPL | 2020-01-07 |
| 61528 | SUPPL | 2020-01-07 |
| 58364 | SUPPL | 2019-04-22 |
| 58344 | SUPPL | 2019-04-18 |
| 54685 | SUPPL | 2018-06-26 |
| 54643 | SUPPL | 2018-06-21 |
| 50684 | SUPPL | 2017-12-13 |
| 50683 | SUPPL | 2017-12-13 |
| 50672 | SUPPL | 2017-12-13 |
| 50671 | SUPPL | 2017-12-13 |
| 50614 | SUPPL | 2017-12-06 |
| 48606 | SUPPL | 2017-05-31 |
| 9553 | SUPPL | 2016-05-03 |
| 39794 | SUPPL | 2016-04-29 |
| 31778 | SUPPL | 2015-12-23 |
| 39792 | SUPPL | 2015-11-19 |
| 62324 | SUPPL | 2015-11-13 |
| 39793 | SUPPL | 2015-10-06 |
| 39791 | SUPPL | 2015-10-06 |
| 18739 | SUPPL | 2015-10-06 |
| 31777 | SUPPL | 2015-09-24 |
| 9552 | SUPPL | 2015-09-24 |
| 9550 | SUPPL | 2015-09-24 |
| 9551 | SUPPL | 2014-12-30 |
| 39790 | SUPPL | 2012-05-29 |
| 31776 | SUPPL | 2012-05-29 |
| 31775 | SUPPL | 2011-06-15 |
| 9549 | SUPPL | 2010-03-31 |
| 31774 | SUPPL | 2008-12-04 |
| 9547 | SUPPL | 2008-12-04 |
| 9548 | SUPPL | 2008-05-22 |
| 18738 | SUPPL | 2007-08-02 |
| 9546 | SUPPL | 2007-08-01 |
| 39789 | SUPPL | 2006-11-09 |
| 31773 | SUPPL | 2006-11-09 |
| 18737 | SUPPL | 2006-02-08 |
| 39788 | SUPPL | 2005-01-26 |
| 39787 | SUPPL | 2005-01-26 |
| 9545 | SUPPL | 2005-01-26 |
| 9544 | SUPPL | 2005-01-26 |
| 22771 | ORIG | 2004-10-25 |
| 43577 | ORIG | 2004-03-25 |
| 18736 | ORIG | 2004-03-25 |
| 9543 | ORIG | 2004-03-25 |
| 53385 | ORIG | 1900-01-01 |
| 53384 | ORIG | 1900-01-01 |