Documents
Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | EQ 400MG BASE | 1 | AVELOX | MOXIFLOXACIN HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1999-12-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2000-04-21 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2001-05-17 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2001-05-17 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2002-06-12 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2002-06-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2001-02-02 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2001-04-27 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2002-05-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2002-12-10 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2003-02-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2003-02-28 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2003-02-28 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2003-10-06 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 22 | AP | 2004-05-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 23 | AP | 2004-03-06 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2004-07-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2004-12-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 26 | AP | 2005-06-13 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 27 | AP | 2005-11-22 | UNKNOWN |
| LABELING; Labeling | SUPPL | 29 | AP | 2005-11-22 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2007-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2008-02-15 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2008-12-29 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2008-10-03 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2009-06-24 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2009-04-27 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2010-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2009-11-24 | UNKNOWN |
| LABELING; Labeling | SUPPL | 46 | AP | 2010-03-02 | UNKNOWN |
| LABELING; Labeling | SUPPL | 47 | AP | 2011-02-25 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 50 | AP | 2011-10-18 | STANDARD |
| REMS; REMS | SUPPL | 52 | AP | 2011-08-03 | N/A |
| LABELING; Labeling | SUPPL | 53 | AP | 2011-10-18 | UNKNOWN |
| LABELING; Labeling | SUPPL | 55 | AP | 2012-08-24 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 2012-12-18 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2013-08-14 | 901 REQUIRED |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 2014-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 59 | AP | 2014-11-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 60 | AP | 2015-05-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 61 | AP | 2016-09-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 62 | AP | 2016-09-27 | STANDARD |
| LABELING; Labeling | SUPPL | 63 | AP | 2016-07-26 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 64 | AP | 2018-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 65 | AP | 2019-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 66 | AP | 2020-05-06 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 23 | Null | 9 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 42 | Null | 7 |
| SUPPL | 44 | Null | 7 |
| SUPPL | 45 | Null | 6 |
| SUPPL | 46 | Null | 6 |
| SUPPL | 47 | Null | 6 |
| SUPPL | 50 | Null | 7 |
| SUPPL | 52 | Null | 6 |
| SUPPL | 53 | Null | 6 |
| SUPPL | 55 | Null | 7 |
| SUPPL | 56 | Null | 7 |
| SUPPL | 57 | Null | 7 |
| SUPPL | 58 | Null | 0 |
| SUPPL | 59 | Null | 15 |
| SUPPL | 60 | Null | 15 |
| SUPPL | 61 | Null | 6 |
| SUPPL | 62 | Null | 7 |
| SUPPL | 63 | Null | 15 |
| SUPPL | 64 | Null | 6 |
| SUPPL | 65 | Null | 6 |
| SUPPL | 66 | Null | 6 |
TE Codes
CDER Filings
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