Documents
Application Sponsors
Marketing Status
Application Products
| 001 | INJECTABLE;INTRAVENOUS | 200MG/VIAL | 1 | VFEND | VORICONAZOLE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2002-05-24 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | 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 | 11 | AP | 2005-07-07 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | 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 | 19 | AP | 2006-05-19 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2006-12-01 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | 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 | 29 | AP | 2010-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2010-06-17 | UNKNOWN |
| LABELING; Labeling | SUPPL | 33 | AP | 2010-06-17 | UNKNOWN |
| LABELING; Labeling | SUPPL | 34 | AP | 2010-12-15 | UNKNOWN |
| LABELING; Labeling | SUPPL | 36 | AP | 2010-11-21 | UNKNOWN |
| LABELING; Labeling | SUPPL | 37 | AP | 2011-06-01 | UNKNOWN |
| LABELING; Labeling | SUPPL | 40 | AP | 2011-11-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 2013-07-25 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2014-04-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 2014-06-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 2014-06-24 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2015-02-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 2016-01-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 50 | AP | 2019-01-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 53 | AP | 2017-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | 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 | 55 | AP | 2019-04-30 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2021-01-14 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2020-09-04 | STANDARD |
| LABELING; Labeling | SUPPL | 59 | AP | 2021-01-25 | STANDARD |
| LABELING; Labeling | SUPPL | 60 | AP | 2021-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 61 | AP | 2021-10-13 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2022-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 63 | AP | 2022-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 64 | AP | 2022-08-16 | STANDARD |
Submissions Property Types
| SUPPL | 25 | Null | 7 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 32 | Null | 7 |
| SUPPL | 33 | Null | 6 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 36 | Null | 7 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 40 | Null | 7 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 44 | Null | 7 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 6 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 50 | Null | 15 |
| SUPPL | 53 | Null | 7 |
| SUPPL | 54 | Null | 7 |
| SUPPL | 55 | Null | 15 |
| SUPPL | 57 | Null | 7 |
| SUPPL | 58 | Null | 7 |
| SUPPL | 59 | Null | 6 |
| SUPPL | 60 | Null | 6 |
| SUPPL | 61 | Null | 6 |
| SUPPL | 62 | Null | 7 |
| SUPPL | 63 | Null | 15 |
| SUPPL | 64 | Null | 7 |
TE Codes
CDER Filings
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