Application 125293
- Type
- BLA
- Sponsor
- HORIZON PHARMA
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KRYSTEXXA | PEGLOTICASE | INJECTABLE; INJECTION | 8MG | Yes | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 54396-801 | Krystexxa | pegloticase | Savient Pharmaceuticals, Inc. | BLA | Current |
| 60809-801 | Krystexxa | pegloticase | Horizon Pharma Inc. | BLA | Current |
| 75987-080 | Krystexxa | pegloticase | Horizon Therapeutics USA, Inc. | BLA | Current |
| 75987-080 | Krystexxa | pegloticase | Horizon Therapeutics USA, Inc. | BLA | Current |
| 75987-080 | Krystexxa | pegloticase | Horizon Therapeutics USA, Inc. | BLA | Current |
| 75987-080 | Krystexxa | pegloticase | Horizon Therapeutics USA, Inc. | BLA | Current |
| 75987-080 | Krystexxa | pegloticase | Horizon Pharma Inc. | BLA | Current |
| 75987-080 | Krystexxa | pegloticase | Horizon Therapeutics USA, Inc. | BLA | Current |
| 75987-080 | Krystexxa | pegloticase | Horizon Therapeutics USA, Inc. | BLA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 71541 | SUPPL | 2022-07-13 |
| 71540 | SUPPL | 2022-07-13 |
| 71530 | SUPPL | 2022-07-08 |
| 56372 | SUPPL | 2018-11-08 |
| 54921 | SUPPL | 2018-07-20 |
| 54903 | SUPPL | 2018-07-16 |
| 46966 | SUPPL | 2017-01-24 |
| 45298 | SUPPL | 2016-09-15 |
| 9693 | SUPPL | 2016-05-16 |
| 39913 | SUPPL | 2016-05-11 |
| 31916 | SUPPL | 2016-04-12 |
| 31915 | SUPPL | 2015-07-31 |
| 18857 | SUPPL | 2015-07-22 |
| 9692 | SUPPL | 2015-07-20 |
| 31914 | SUPPL | 2013-10-16 |
| 9691 | SUPPL | 2012-04-18 |
| 9690 | SUPPL | 2012-04-18 |
| 39912 | SUPPL | 2012-04-16 |
| 18856 | SUPPL | 2012-04-16 |
| 24362 | ORIG | 2011-02-17 |
| 43317 | ORIG | 2010-11-12 |
| 9689 | SUPPL | 2010-10-26 |
| 23462 | ORIG | 2010-09-30 |
| 39911 | ORIG | 2010-09-20 |
| 31913 | ORIG | 2010-09-20 |