Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 50MG | 1 | VFEND | VORICONAZOLE |
| 002 | TABLET;ORAL | 200MG | 1 | VFEND | VORICONAZOLE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2002-05-24 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2003-03-28 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2004-04-21 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2004-04-21 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2004-02-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2004-12-21 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2005-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2005-07-07 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2005-12-18 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2006-03-10 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2008-02-05 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2006-05-19 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2006-12-01 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2010-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2008-03-10 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2010-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2008-05-30 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2010-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2010-06-17 | UNKNOWN |
| LABELING; Labeling | SUPPL | 30 | AP | 2010-06-17 | UNKNOWN |
| LABELING; Labeling | SUPPL | 31 | AP | 2010-12-15 | UNKNOWN |
| LABELING; Labeling | SUPPL | 32 | AP | 2010-11-21 | UNKNOWN |
| LABELING; Labeling | SUPPL | 33 | AP | 2011-06-01 | UNKNOWN |
| LABELING; Labeling | SUPPL | 34 | AP | 2010-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2011-11-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2013-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2014-04-07 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2015-02-03 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 39 | AP | 2019-01-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 41 | AP | 2017-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2017-07-28 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 45 | AP | 2019-04-30 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2021-01-14 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2020-09-04 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2021-01-25 | STANDARD |
| LABELING; Labeling | SUPPL | 50 | AP | 2021-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 2021-10-13 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2022-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2022-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | AP | 2022-08-16 | STANDARD |
Submissions Property Types
| SUPPL | 22 | Null | 0 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 27 | Null | 7 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 30 | Null | 6 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 33 | Null | 6 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 15 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 15 |
| SUPPL | 38 | Null | 15 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 41 | Null | 15 |
| SUPPL | 43 | Null | 6 |
| SUPPL | 45 | Null | 15 |
| SUPPL | 47 | Null | 7 |
| SUPPL | 48 | Null | 6 |
| SUPPL | 49 | Null | 6 |
| SUPPL | 50 | Null | 6 |
| SUPPL | 51 | Null | 7 |
| SUPPL | 52 | Null | 7 |
| SUPPL | 53 | Null | 15 |
| SUPPL | 54 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
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