Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | CIPRO XR | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 0 | CIPRO XR | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2002-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2004-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2004-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2004-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2005-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2005-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2006-06-19 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2007-06-25 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2008-01-18 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2008-10-03 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2009-04-27 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2009-06-24 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2011-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2011-02-25 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 31 | AP | 2011-06-10 | STANDARD |
| REMS; REMS | SUPPL | 32 | AP | 2011-08-03 | N/A |
| LABELING; Labeling | SUPPL | 33 | AP | 2011-10-18 | UNKNOWN |
| LABELING; Labeling | SUPPL | 34 | AP | 2013-01-30 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2013-08-14 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 36 | AP | 2015-01-30 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2016-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | 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 | 39 | AP | 2018-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2019-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2020-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2020-05-08 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2021-03-30 | STANDARD |
Submissions Property Types
| SUPPL | 5 | Null | 9 |
| SUPPL | 6 | Null | 9 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 27 | Null | 7 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 31 | Null | 7 |
| SUPPL | 32 | Null | 7 |
| SUPPL | 33 | Null | 15 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 36 | Null | 7 |
| SUPPL | 37 | Null | 7 |
| SUPPL | 38 | Null | 15 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 40 | Null | 6 |
| SUPPL | 41 | Null | 6 |
| SUPPL | 42 | Null | 7 |
| SUPPL | 43 | Null | 15 |
CDER Filings
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