Application 125268
- Type
- BLA
- Sponsor
- AMGEN
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NPLATE | ROMIPLOSTIM | INJECTABLE; SUBCUTANEOUS | 250MCG/0.5ML; 500MCG/1ML. | Yes | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55513-221 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-221 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-221 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-221 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-221 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-221 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-221 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-221 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-221 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-221 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-222 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-222 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-222 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-222 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-222 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-222 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-222 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-222 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-222 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-222 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-223 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-223 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-223 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-223 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-223 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-223 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-223 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-223 | Nplate | romiplostim | Amgen Inc | BLA | Current |
| 55513-223 | Nplate | romiplostim | Amgen Inc | BLA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 81771 | SUPPL | 2025-03-28 |
| 81357 | SUPPL | 2025-02-25 |
| 81341 | SUPPL | 2025-02-24 |
| 81340 | SUPPL | 2025-02-21 |
| 70149 | SUPPL | 2022-02-14 |
| 70146 | SUPPL | 2022-02-11 |
| 66234 | SUPPL | 2021-02-16 |
| 66195 | SUPPL | 2021-02-11 |
| 66046 | SUPPL | 2021-02-01 |
| 66027 | SUPPL | 2021-02-01 |
| 66017 | SUPPL | 2021-01-29 |
| 66016 | SUPPL | 2021-01-29 |
| 65327 | SUPPL | 2020-11-25 |
| 65322 | SUPPL | 2020-11-25 |
| 60588 | SUPPL | 2019-10-18 |
| 60583 | SUPPL | 2019-10-18 |
| 60582 | SUPPL | 2019-10-18 |
| 56913 | SUPPL | 2018-12-21 |
| 56745 | SUPPL | 2018-12-14 |
| 48658 | SUPPL | 2017-06-06 |
| 48657 | SUPPL | 2017-06-06 |
| 39888 | SUPPL | 2016-04-20 |
| 31880 | SUPPL | 2016-04-20 |
| 18831 | SUPPL | 2016-04-20 |
| 9660 | SUPPL | 2016-04-20 |
| 31879 | SUPPL | 2014-02-12 |
| 18830 | SUPPL | 2014-02-11 |
| 39887 | SUPPL | 2013-06-04 |
| 9659 | SUPPL | 2013-05-31 |
| 31878 | SUPPL | 2012-11-07 |
| 39886 | SUPPL | 2012-11-06 |
| 31877 | SUPPL | 2011-12-14 |
| 18829 | SUPPL | 2011-12-06 |
| 9658 | SUPPL | 2010-06-10 |
| 9657 | SUPPL | 2010-06-10 |
| 18828 | SUPPL | 2009-09-18 |
| 31876 | SUPPL | 2009-09-09 |
| 44563 | ORIG | 2008-10-22 |
| 44794 | ORIG | 2008-10-17 |
| 22793 | ORIG | 2008-10-17 |
| 31875 | ORIG | 2008-08-25 |
| 18827 | ORIG | 2008-08-25 |