Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021473
Company: BAYER HLTHCARE
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPRO XR | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| CIPRO XR | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/13/2002 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21473_ciproXR_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21473ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-473_Cipro.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/30/2021 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021473s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021473Orig1s043ltr.pdf | |
| 05/08/2020 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021473s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021473Orig1s042ltr.pdf | |
| 03/05/2020 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021473s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021473Orig1s041ltr.pdf | |
| 05/03/2019 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021473s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021473Orig1s040ltr.pdf | |
| 10/18/2018 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021473s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021473Orig1s039ltr.pdf | |
| 07/26/2017 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021473s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021473Orig1s038ltr.pdf |
| 07/26/2016 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021473s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537s086,019847s057,019857s065,020780s043,021473Orig1s037ltr.pdf | |
| 01/30/2015 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021473s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021473Orig1s036ltr.pdf | |
| 08/14/2013 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021473s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021473Orig1s035ltr.pdf | |
| 01/30/2013 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021473s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021473Orig1s034ltr.pdf | |
| 10/18/2011 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s080,019847s052,019857s059,020780s038,021473s033ltr.pdf | |
| 08/03/2011 | SUPPL-32 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s079,019847s051,019857s058,020780s037,021473s032ltr.pdf |
| 06/10/2011 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021473s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021473s031ltr.pdf | |
| 02/25/2011 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021473s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s075,019847s047,019857s054,020780s033,021473s028ltr.pdf | |
| 11/15/2011 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021473s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021473s027ltr.pdf | |
| 06/24/2009 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s071,019847s045,019857s052,020780s029,021473s026ltr.pdf |
| 04/27/2009 | SUPPL-25 | REMS-Proposal, Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020780s028,021473s025ltr.pdf | |
| 10/03/2008 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019857s049,020780s026,021473s024ltr.pdf | |
| 01/18/2008 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021473s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021473s023ltr.pdf | |
| 06/25/2007 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021473s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,19857s46,20780s24,21473s22ltr.pdf | |
| 06/19/2006 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/09/2005 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s60,019847s36,019857s41,020780s20,021473s13ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021473_S013_CIPRO.pdf | |
| 05/18/2005 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021473s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021473s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021473_S009_CIPRO.pdf | |
| 07/14/2004 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21473s005,006,007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21473s005,006,007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021473_S007_CIPRO.pdf | |
| 07/14/2004 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21473s005,006,007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21473s005,006,007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021473_S006_CIPRO.pdf | |
| 07/14/2004 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21473s005,006,007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21473s005,006,007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021473_S005_CIPRO.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/30/2021 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021473s043lbl.pdf | |
| 05/08/2020 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021473s042lbl.pdf | |
| 03/05/2020 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021473s041lbl.pdf | |
| 05/03/2019 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021473s040lbl.pdf | |
| 10/18/2018 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021473s039lbl.pdf | |
| 07/26/2017 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021473s038lbl.pdf |
| 07/26/2016 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021473s037lbl.pdf | |
| 01/30/2015 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021473s036lbl.pdf | |
| 08/14/2013 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021473s035lbl.pdf | |
| 01/30/2013 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021473s034lbl.pdf | |
| 11/15/2011 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021473s027lbl.pdf | |
| 10/18/2011 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf | |
| 06/10/2011 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021473s031lbl.pdf | |
| 02/25/2011 | SUPPL-28 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021473s028lbl.pdf | |
| 02/25/2011 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021473s028lbl.pdf | |
| 04/27/2009 | SUPPL-25 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf | |
| 04/27/2009 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf | |
| 10/03/2008 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf | |
| 01/18/2008 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021473s023lbl.pdf | |
| 06/25/2007 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021473s022lbl.pdf | |
| 11/09/2005 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf | |
| 05/18/2005 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021473s009lbl.pdf | |
| 07/14/2004 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21473s005,006,007lbl.pdf | |
| 07/14/2004 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21473s005,006,007lbl.pdf | |
| 07/14/2004 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21473s005,006,007lbl.pdf | |
| 12/13/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21473_ciproXR_lbl.pdf |