Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN |
| 002 | INJECTABLE;INJECTION | 400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1990-12-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1991-04-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1992-05-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1992-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1995-10-25 | |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 1996-10-21 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1993-12-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1994-04-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 1996-10-10 | UNKNOWN |
| LABELING; Labeling | SUPPL | 13 | AP | 1997-09-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 1998-04-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1996-06-28 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1996-08-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 1997-08-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1997-08-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 1998-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 1998-09-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 1998-09-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1998-11-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1999-01-07 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 1998-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2000-06-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1999-06-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 27 | AP | 2000-08-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 28 | AP | 2002-04-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2002-12-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 31 | AP | 2004-03-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 33 | AP | 2004-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2004-07-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 35 | AP | 2005-01-07 | UNKNOWN |
| LABELING; Labeling | SUPPL | 36 | AP | 2004-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2005-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2005-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2006-06-19 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2007-06-25 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2008-01-18 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2008-10-03 | STANDARD |
| LABELING; Labeling | SUPPL | 50 | AP | 2009-02-13 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 2009-04-27 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2009-06-24 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2011-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | AP | 2011-02-25 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 57 | AP | 2011-08-12 | STANDARD |
| REMS; REMS | SUPPL | 58 | AP | 2011-08-03 | N/A |
| LABELING; Labeling | SUPPL | 59 | AP | 2011-10-18 | UNKNOWN |
| LABELING; Labeling | SUPPL | 60 | AP | 2013-01-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 2013-10-14 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2013-08-14 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 63 | AP | 2015-02-02 | STANDARD |
| LABELING; Labeling | SUPPL | 64 | AP | 2015-03-19 | STANDARD |
| LABELING; Labeling | SUPPL | 65 | AP | 2016-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 66 | 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 | 68 | AP | 2018-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 69 | AP | 2019-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 70 | AP | 2020-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 72 | AP | 2020-05-08 | STANDARD |
| LABELING; Labeling | SUPPL | 73 | AP | 2022-03-25 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 41 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 31 | Null | 9 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 51 | Null | 7 |
| SUPPL | 53 | Null | 15 |
| SUPPL | 54 | Null | 6 |
| SUPPL | 57 | Null | 15 |
| SUPPL | 58 | Null | 6 |
| SUPPL | 59 | Null | 6 |
| SUPPL | 60 | Null | 6 |
| SUPPL | 61 | Null | 0 |
| SUPPL | 62 | Null | 6 |
| SUPPL | 63 | Null | 7 |
| SUPPL | 64 | Null | 7 |
| SUPPL | 65 | Null | 15 |
| SUPPL | 66 | Null | 6 |
| SUPPL | 68 | Null | 15 |
| SUPPL | 69 | Null | 6 |
| SUPPL | 70 | Null | 6 |
| SUPPL | 72 | Null | 6 |
| SUPPL | 73 | Null | 6 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 19857
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)