Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | FOR SUSPENSION;ORAL | 250MG/5ML | 1 | CIPRO | CIPROFLOXACIN |
| 002 | FOR SUSPENSION;ORAL | 500MG/5ML | 1 | CIPRO | CIPROFLOXACIN |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1997-09-26 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1998-09-17 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1998-09-17 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1998-09-17 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1999-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2000-06-28 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2000-06-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2000-08-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 2000-06-28 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2000-06-28 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2002-04-17 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2004-03-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2004-03-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 14 | AP | 2004-03-15 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2004-03-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2005-01-07 | UNKNOWN |
| LABELING; Labeling | SUPPL | 17 | AP | 2004-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2004-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2005-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2005-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2006-06-19 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2007-06-25 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2008-01-18 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2008-10-03 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2009-02-13 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2009-04-27 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2009-06-24 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2009-04-06 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2011-11-15 | UNKNOWN |
| LABELING; Labeling | SUPPL | 33 | AP | 2011-02-25 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 36 | AP | 2011-06-10 | STANDARD |
| REMS; REMS | SUPPL | 37 | AP | 2011-08-03 | N/A |
| LABELING; Labeling | SUPPL | 38 | AP | 2011-10-18 | UNKNOWN |
| LABELING; Labeling | SUPPL | 39 | AP | 2013-01-30 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2013-08-14 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 41 | AP | 2015-02-02 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2016-09-14 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2016-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2017-07-26 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 45 | AP | 2018-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2019-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2020-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2020-05-08 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2021-03-30 | STANDARD |
Submissions Property Types
| SUPPL | 8 | Null | 41 |
| SUPPL | 12 | Null | 9 |
| SUPPL | 13 | Null | 9 |
| SUPPL | 14 | Null | 9 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 33 | Null | 6 |
| SUPPL | 36 | Null | 7 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 38 | Null | 6 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 40 | Null | 7 |
| SUPPL | 41 | Null | 40 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 43 | Null | 6 |
| SUPPL | 44 | Null | 6 |
| SUPPL | 45 | Null | 7 |
| SUPPL | 46 | Null | 7 |
| SUPPL | 47 | Null | 15 |
| SUPPL | 48 | Null | 15 |
| SUPPL | 49 | Null | 6 |
CDER Filings
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