Application 125338
- Type
- BLA
- Sponsor
- AUXILIUM PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XIAFLEX | COLLAGENASE CLOSTRIDIUM HISTOLYTICUM | SOLUTION; INJECTION | 0.9MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66887-003 | XIAFLEX | collagenase clostridium histolyticum | Endo Pharmaceuticals Inc. | BLA | Current |
| 66887-003 | XIAFLEX | collagenase clostridium histolyticum | Endo Pharmaceuticals, Inc. | BLA | Current |
| 66887-003 | XIAFLEX | collagenase clostridium histolyticum | Endo Pharmaceuticals Inc. | BLA | Current |
| 66887-003 | XIAFLEX | collagenase clostridium histolyticum | Endo Pharmaceuticals Inc. | BLA | Current |
| 66887-003 | XIAFLEX | collagenase clostridium histolyticum | Endo Pharmaceuticals Inc. | BLA | Current |
| 66887-003 | XIAFLEX | collagenase clostridium histolyticum | Endo Pharmaceuticals Inc. | BLA | Current |
| 66887-003 | XIAFLEX | collagenase clostridium histolyticum | Endo Pharmaceuticals Inc. | BLA | Current |
| 66887-003 | XIAFLEX | collagenase clostridium histolyticum | Endo Pharmaceuticals Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79903 | SUPPL | 2024-10-15 |
| 74766 | SUPPL | 2023-07-14 |
| 74765 | SUPPL | 2023-07-14 |
| 74747 | SUPPL | 2023-07-13 |
| 72551 | SUPPL | 2022-11-03 |
| 71715 | SUPPL | 2022-08-04 |
| 71692 | SUPPL | 2022-08-02 |
| 71263 | SUPPL | 2022-06-10 |
| 69844 | SUPPL | 2022-01-12 |
| 68444 | SUPPL | 2021-08-24 |
| 68435 | SUPPL | 2021-08-22 |
| 68434 | SUPPL | 2021-08-22 |
| 67085 | SUPPL | 2021-04-16 |
| 67084 | SUPPL | 2021-04-16 |
| 67052 | SUPPL | 2021-04-14 |
| 55759 | SUPPL | 2018-10-01 |
| 54563 | SUPPL | 2018-06-14 |
| 54487 | SUPPL | 2018-06-08 |
| 45965 | SUPPL | 2016-11-29 |
| 45964 | SUPPL | 2016-11-29 |
| 45355 | SUPPL | 2016-09-21 |
| 45370 | SUPPL | 2016-09-20 |
| 39935 | SUPPL | 2015-05-21 |
| 18879 | SUPPL | 2015-05-21 |
| 18878 | SUPPL | 2015-05-21 |
| 31939 | SUPPL | 2015-05-20 |
| 9714 | SUPPL | 2015-05-20 |
| 9713 | SUPPL | 2015-05-20 |
| 9712 | SUPPL | 2014-10-22 |
| 18877 | SUPPL | 2014-10-21 |
| 18876 | SUPPL | 2013-12-12 |
| 31938 | SUPPL | 2013-12-10 |
| 43934 | SUPPL | 2012-02-28 |
| 39934 | SUPPL | 2012-02-28 |
| 9711 | SUPPL | 2012-02-27 |
| 44565 | ORIG | 2010-04-15 |
| 44802 | ORIG | 2010-03-19 |
| 43322 | ORIG | 2010-03-19 |
| 31937 | ORIG | 2010-02-18 |
| 39933 | ORIG | 2010-02-16 |