Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | POWDER;INTRAVENOUS | 50MG/VIAL | 1 | CANCIDAS | CASPOFUNGIN ACETATE |
| 002 | POWDER;INTRAVENOUS | 70MG/VIAL | 1 | CANCIDAS | CASPOFUNGIN ACETATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2001-01-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2002-09-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-04-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 5 | AP | 2002-11-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-06-12 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2003-01-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2002-11-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2002-12-10 | PRIORITY |
| LABELING; Labeling | SUPPL | 11 | AP | 2004-03-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2004-09-29 | UNKNOWN |
| LABELING; Labeling | SUPPL | 14 | AP | 2004-03-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2005-02-16 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2008-07-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 22 | AP | 2008-07-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 2009-06-26 | UNKNOWN |
| LABELING; Labeling | SUPPL | 24 | AP | 2009-05-04 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2010-01-28 | UNKNOWN |
| LABELING; Labeling | SUPPL | 28 | AP | 2010-10-22 | UNKNOWN |
| LABELING; Labeling | SUPPL | 29 | AP | 2012-04-30 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2013-08-02 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2013-01-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2013-12-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 33 | AP | 2014-10-23 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2016-04-12 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2016-04-12 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2017-08-09 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2017-08-25 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 38 | AP | 2018-03-13 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2019-02-08 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2021-10-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 9 |
| SUPPL | 21 | Null | 8 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 27 | Null | 6 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 31 | Null | 15 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 15 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 35 | Null | 7 |
| SUPPL | 36 | Null | 7 |
| SUPPL | 37 | Null | 15 |
| SUPPL | 38 | Null | 6 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 40 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
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