Documents
Application Sponsors
Marketing Status
Application Products
| 001 | POWDER;INTRAVENOUS | 50MG/VIAL | 1 | TYGACIL | TIGECYCLINE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2005-06-15 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2006-07-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2006-07-12 | N/A |
| LABELING; Labeling | SUPPL | 6 | AP | 2007-01-24 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2007-04-03 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2007-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2009-01-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2009-03-20 | UNKNOWN |
| LABELING; Labeling | SUPPL | 14 | AP | 2009-01-29 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2009-02-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2009-03-20 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2009-03-20 | UNKNOWN |
| LABELING; Labeling | SUPPL | 19 | AP | 2009-01-29 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2010-07-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2009-06-26 | N/A |
| LABELING; Labeling | SUPPL | 25 | AP | 2010-07-16 | UNKNOWN |
| LABELING; Labeling | SUPPL | 26 | AP | 2013-09-26 | UNKNOWN |
| LABELING; Labeling | SUPPL | 27 | AP | 2010-07-16 | UNKNOWN |
| LABELING; Labeling | SUPPL | 31 | AP | 2013-09-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2014-01-09 | PRIORITY |
| LABELING; Labeling | SUPPL | 37 | AP | 2013-05-23 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2016-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2016-06-29 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 43 | AP | 2016-01-19 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2018-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2020-01-16 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2020-06-23 | STANDARD |
Submissions Property Types
| SUPPL | 21 | Null | 7 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 26 | Null | 6 |
| SUPPL | 27 | Null | 6 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 15 |
| SUPPL | 39 | Null | 15 |
| SUPPL | 42 | Null | 7 |
| SUPPL | 43 | Null | 7 |
| SUPPL | 45 | Null | 7 |
| SUPPL | 48 | Null | 6 |
| SUPPL | 49 | Null | 6 |
TE Codes
CDER Filings
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