Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | 400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CIPRO | CIPROFLOXACIN |
| 002 | INJECTABLE;INJECTION | 200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CIPRO | CIPROFLOXACIN |
| 003 | INJECTABLE;INJECTION | 1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | CIPRO | CIPROFLOXACIN |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1990-12-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1992-05-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1992-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1995-10-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1993-02-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 1996-10-21 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1993-06-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 1996-10-10 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 1997-09-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 1998-04-03 | UNKNOWN |
| LABELING; Labeling | SUPPL | 14 | AP | 1996-08-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 1997-08-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 1998-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 1998-09-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 1998-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 1998-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2000-06-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1999-11-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 24 | AP | 2000-08-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2000-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2002-04-17 | |
| EFFICACY; Efficacy | SUPPL | 27 | AP | 2004-03-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 28 | AP | 2004-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2004-07-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 30 | AP | 2005-01-07 | UNKNOWN |
| LABELING; Labeling | SUPPL | 31 | AP | 2004-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2005-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2005-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2006-06-19 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2007-06-25 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2008-01-18 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2008-10-03 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2009-02-13 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2009-04-27 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2009-06-24 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2011-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2011-02-25 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 50 | AP | 2011-08-12 | UNKNOWN |
| REMS; REMS | SUPPL | 51 | AP | 2011-08-03 | N/A |
| LABELING; Labeling | SUPPL | 52 | AP | 2011-10-18 | UNKNOWN |
| LABELING; Labeling | SUPPL | 53 | AP | 2013-01-30 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | AP | 2013-08-14 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 55 | AP | 2015-02-02 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 2015-03-19 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2016-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | 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 | 59 | AP | 2018-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 60 | AP | 2019-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 61 | AP | 2020-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2020-05-08 | STANDARD |
| LABELING; Labeling | SUPPL | 63 | AP | 2022-03-25 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 41 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 9 |
| SUPPL | 44 | Null | 7 |
| SUPPL | 46 | Null | 15 |
| SUPPL | 47 | Null | 6 |
| SUPPL | 50 | Null | 7 |
| SUPPL | 51 | Null | 7 |
| SUPPL | 52 | Null | 15 |
| SUPPL | 53 | Null | 15 |
| SUPPL | 54 | Null | 6 |
| SUPPL | 55 | Null | 7 |
| SUPPL | 56 | Null | 7 |
| SUPPL | 57 | Null | 7 |
| SUPPL | 58 | Null | 15 |
| SUPPL | 59 | Null | 6 |
| SUPPL | 60 | Null | 6 |
| SUPPL | 61 | Null | 7 |
| SUPPL | 62 | Null | 7 |
| SUPPL | 63 | Null | 15 |
CDER Filings
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