Documents
Application Sponsors
Marketing Status
Application Products
| 001 | FOR SUSPENSION;ORAL | 200MG/5ML | 1 | VFEND | VORICONAZOLE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2003-12-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2004-12-21 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2005-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2005-07-07 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2005-12-18 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2006-03-10 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2008-02-05 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2006-05-19 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2006-12-01 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2008-03-10 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2010-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2008-05-30 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2010-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2010-06-17 | UNKNOWN |
| LABELING; Labeling | SUPPL | 21 | AP | 2010-06-17 | UNKNOWN |
| LABELING; Labeling | SUPPL | 22 | AP | 2010-12-15 | UNKNOWN |
| LABELING; Labeling | SUPPL | 23 | AP | 2010-11-21 | UNKNOWN |
| LABELING; Labeling | SUPPL | 24 | AP | 2011-06-01 | UNKNOWN |
| LABELING; Labeling | SUPPL | 26 | AP | 2011-11-16 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2014-04-07 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2015-02-03 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 2019-01-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 31 | AP | 2017-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | 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 | 33 | AP | 2018-10-04 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2019-04-30 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2021-01-14 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2020-09-04 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2021-01-25 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2021-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2021-10-13 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2022-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2022-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2022-08-16 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 9 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 27 | Null | 15 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 33 | Null | 7 |
| SUPPL | 34 | Null | 7 |
| SUPPL | 36 | Null | 7 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 38 | Null | 6 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 40 | Null | 6 |
| SUPPL | 41 | Null | 7 |
| SUPPL | 42 | Null | 7 |
| SUPPL | 43 | Null | 6 |
TE Codes
CDER Filings
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