Application 021267
- Type
- NDA
- Sponsor
- PF PRISM CV
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VFEND | VORICONAZOLE | INJECTABLE;INTRAVENOUS | 200MG/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | Voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | Voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | Voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | Voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | Voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | Voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | Voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | Voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | Voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | Voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | voriconazole | Roerig | NDA | Current |
| 0049-3190 | VFEND | Voriconazole | Roerig | NDA | Current |
| 0049-4190 | VFEND | VORICONAZOLE | Roerig | NDA | Current |
| 0049-4190 | VFEND | VORICONAZOLE | Roerig | NDA | Current |
| 0049-4190 | VFEND | VORICONAZOLE | Roerig | NDA | Current |
| 0049-4190 | VFEND | VORICONAZOLE | Roerig | NDA | Current |
| 0049-4190 | VFEND | VORICONAZOLE | Roerig | NDA | Current |
| 0049-4190 | VFEND | VORICONAZOLE | Roerig | NDA | Current |
| 0049-4190 | VFEND | VORICONAZOLE | Roerig | NDA | Current |
| 0049-4190 | VFEND | VORICONAZOLE | Roerig | NDA | Current |
| 0049-4190 | VFEND | VORICONAZOLE | Roerig | NDA | Current |
| 0049-4190 | VFEND | VORICONAZOLE | Roerig | NDA | Current |
| 0049-4190 | VFEND | VORICONAZOLE | Roerig | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85126 | SUPPL | 2026-02-24 |
| 85105 | SUPPL | 2026-02-23 |
| 84876 | SUPPL | 2026-01-29 |
| 84870 | SUPPL | 2026-01-29 |
| 81576 | SUPPL | 2025-03-17 |
| 81559 | SUPPL | 2025-03-14 |
| 72432 | SUPPL | 2022-10-21 |
| 72409 | SUPPL | 2022-10-19 |
| 71831 | SUPPL | 2022-08-17 |
| 71819 | SUPPL | 2022-08-17 |
| 70031 | SUPPL | 2022-02-01 |
| 70013 | SUPPL | 2022-01-31 |
| 68996 | SUPPL | 2021-10-14 |
| 68984 | SUPPL | 2021-10-14 |
| 67095 | SUPPL | 2021-04-19 |
| 67092 | SUPPL | 2021-04-19 |
| 65994 | SUPPL | 2021-01-26 |
| 65983 | SUPPL | 2021-01-26 |
| 65979 | SUPPL | 2021-01-26 |
| 65928 | SUPPL | 2021-01-19 |
| 64527 | SUPPL | 2020-09-08 |
| 64522 | SUPPL | 2020-09-08 |
| 58518 | SUPPL | 2019-05-02 |
| 58498 | SUPPL | 2019-05-01 |
| 57558 | SUPPL | 2019-02-13 |
| 57381 | SUPPL | 2019-01-30 |
| 49188 | SUPPL | 2017-08-02 |
| 49158 | SUPPL | 2017-07-31 |
| 48763 | SUPPL | 2017-06-19 |
| 48741 | SUPPL | 2017-06-16 |
| 36524 | SUPPL | 2015-02-05 |
| 27294 | SUPPL | 2015-02-05 |
| 36523 | SUPPL | 2014-04-08 |
| 4847 | SUPPL | 2014-04-08 |
| 42065 | SUPPL | 2012-11-09 |
| 36522 | SUPPL | 2011-11-21 |
| 27293 | SUPPL | 2011-11-21 |
| 14812 | SUPPL | 2011-06-16 |
| 27292 | SUPPL | 2011-06-02 |
| 36520 | SUPPL | 2010-12-26 |
| 27290 | SUPPL | 2010-12-21 |
| 27291 | SUPPL | 2010-11-30 |
| 36521 | SUPPL | 2010-11-21 |
| 36519 | SUPPL | 2010-06-24 |
| 36518 | SUPPL | 2010-06-24 |
| 27289 | SUPPL | 2010-06-24 |
| 27288 | SUPPL | 2010-06-24 |
| 14811 | SUPPL | 2010-06-24 |
| 14810 | SUPPL | 2010-06-24 |
| 4846 | SUPPL | 2010-06-24 |
| 4845 | SUPPL | 2010-06-24 |
| 27287 | SUPPL | 2008-06-03 |
| 27286 | SUPPL | 2008-03-13 |
| 14809 | SUPPL | 2008-03-13 |
| 14807 | SUPPL | 2008-02-14 |
| 27283 | SUPPL | 2008-02-07 |
| 42064 | SUPPL | 2007-01-10 |
| 21560 | SUPPL | 2007-01-10 |
| 27285 | SUPPL | 2006-12-28 |
| 36517 | SUPPL | 2006-12-04 |
| 27284 | SUPPL | 2006-05-22 |
| 14808 | SUPPL | 2006-05-22 |
| 27282 | SUPPL | 2006-03-22 |
| 14806 | SUPPL | 2006-03-22 |
| 4844 | SUPPL | 2006-01-19 |
| 14805 | SUPPL | 2006-01-05 |
| 27281 | SUPPL | 2005-07-15 |
| 14804 | SUPPL | 2005-07-08 |
| 27280 | SUPPL | 2005-03-29 |
| 14803 | SUPPL | 2005-03-29 |
| 36516 | SUPPL | 2004-12-29 |
| 27279 | SUPPL | 2004-12-29 |
| 14799 | ORIG | 2004-06-30 |
| 4840 | ORIG | 2004-06-30 |
| 36515 | SUPPL | 2004-05-04 |
| 14801 | SUPPL | 2004-05-04 |
| 27278 | SUPPL | 2004-04-29 |
| 4842 | SUPPL | 2004-04-29 |
| 14802 | SUPPL | 2004-03-03 |
| 4843 | SUPPL | 2004-02-27 |
| 21559 | ORIG | 2003-12-02 |
| 4841 | SUPPL | 2003-04-14 |
| 14800 | SUPPL | 2003-03-28 |
| 63271 | ORIG | 1900-01-01 |
| 63270 | ORIG | 1900-01-01 |
| 63269 | ORIG | 1900-01-01 |
| 63268 | ORIG | 1900-01-01 |