Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019847
Company: BAYER HLTHCARE
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPRO | CIPROFLOXACIN | 400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| CIPRO | CIPROFLOXACIN | 200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| CIPRO | CIPROFLOXACIN | 1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 12/26/1990 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/25/2022 | SUPPL-63 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019847Orig1s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019847Orig1s063ltr.pdf | |
| 05/08/2020 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019847s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019847Orig1s062ltr.pdf | |
| 03/05/2020 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019847s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019847Orig1s061ltr.pdf | |
| 05/03/2019 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019847s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019847Orig1s060ltr.pdf | |
| 10/18/2018 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019847s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019847Orig1s059ltr.pdf | |
| 07/28/2017 | SUPPL-58 | 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/2017/019847s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019847Orig1s058ltr.pdf |
| 07/26/2016 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019847s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537s086,019847s057,019857s065,020780s043,021473Orig1s037ltr.pdf | |
| 03/19/2015 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s056,019857s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019847Orig1s056,019857Orig1s064ltr.pdf | |
| 02/02/2015 | SUPPL-55 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s055,019857s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019537Orig1s083,019847Orig1s055,019857Orig1s063,020780Orig1s041ltr.pdf | |
| 08/14/2013 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019847s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019847Orig1s054ltr.pdf | |
| 01/30/2013 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019847s053,019857s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019847Orig1s053,019857Orig1s060ltr.pdf | |
| 10/18/2011 | SUPPL-52 | 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-51 | 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 |
| 08/12/2011 | SUPPL-50 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s050,019857s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019847s050,019857s057ltr.pdf | |
| 02/25/2011 | SUPPL-47 | REMS-Modified, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s047,019857s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s075,019847s047,019857s054,020780s033,021473s028ltr.pdf | |
| 11/15/2011 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s046,019857s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019847s046,019857s053ltr.pdf | |
| 06/24/2009 | SUPPL-45 | 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-44 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s070,019847s044ltr.pdf | |
| 02/13/2009 | SUPPL-43 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s069,019847s043,019857s050,020780s027ltr.pdf | |
| 10/03/2008 | SUPPL-42 | 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/2008/019537s068,019847s042ltr.pdf | |
| 01/18/2008 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019847s041,019857s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019847s041ltr.pdf | |
| 06/25/2007 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019847s39lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,19857s46,20780s24,21473s22ltr.pdf | |
| 06/19/2006 | SUPPL-37 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019537s62,020780s23,019847s37,019857s42,021473s16LTR.pdf |
| 11/09/2005 | SUPPL-36 | 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/2005/019847_S036_Cipro.pdf | |
| 05/18/2005 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019847s032,019857s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019847s032,019857s038ltr.pdf | |
| 07/14/2004 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,19857s033,034,036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019847_S031_CIPRO.pdf | |
| 01/07/2005 | SUPPL-30 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s035,20780s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19537s052,19847s030,19857s035,20780s016ltr.pdf | |
| 07/14/2004 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,19857s033,034,036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019847_S029_CIPRO.pdf | |
| 07/14/2004 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,19857s033,034,036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019847_S028_CIPRO.pdf | |
| 03/25/2004 | SUPPL-27 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847se5-027,20780se5-013_cipro_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s049,19857s031,19847s027,20780s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537s49_19847s27_19857s31_20780s13TOC.cfm | |
| 04/17/2002 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19847s26ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019847_S026_CIPRO.pdf | |
| 10/31/2000 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/2000 | SUPPL-24 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20780S08ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-537S038_Cipro.cfm | |
| 11/01/1999 | SUPPL-22 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019847_S022_CIPRO.pdf |
| 06/28/2000 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 09/24/1998 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 09/24/1998 | SUPPL-18 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/24/1998 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/24/1998 | SUPPL-16 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/07/1997 | SUPPL-15 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/09/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/03/1998 | SUPPL-13 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 09/26/1997 | SUPPL-12 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019847_S012_CIPRO.pdf |
| 10/10/1996 | SUPPL-10 | Efficacy-New Indication |
Label is not available on this site. |
||
| 06/14/1993 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/21/1996 | SUPPL-8 | Efficacy-New Indication |
Label is not available on this site. |
||
| 02/12/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/23/1992 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/13/1992 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/13/1992 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/25/2022 | SUPPL-63 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019847Orig1s063lbl.pdf | |
| 03/25/2022 | SUPPL-63 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019847Orig1s063lbl.pdf | |
| 03/25/2022 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019847Orig1s063lbl.pdf | |
| 05/08/2020 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019847s062lbl.pdf | |
| 03/05/2020 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019847s061lbl.pdf | |
| 05/03/2019 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019847s060lbl.pdf | |
| 10/18/2018 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019847s059lbl.pdf | |
| 07/28/2017 | SUPPL-58 | 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/2017/019847s058lbl.pdf |
| 07/26/2016 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019847s057lbl.pdf | |
| 03/19/2015 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s056,019857s064lbl.pdf | |
| 02/02/2015 | SUPPL-55 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s055,019857s063lbl.pdf | |
| 08/14/2013 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019847s054lbl.pdf | |
| 01/30/2013 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019847s053,019857s060lbl.pdf | |
| 11/15/2011 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s046,019857s053lbl.pdf | |
| 10/18/2011 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf | |
| 08/12/2011 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s050,019857s057lbl.pdf | |
| 02/25/2011 | SUPPL-47 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s047,019857s054lbl.pdf | |
| 02/25/2011 | SUPPL-47 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s047,019857s054lbl.pdf | |
| 04/27/2009 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf | |
| 04/27/2009 | SUPPL-44 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf | |
| 02/13/2009 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27lbl.pdf | |
| 10/03/2008 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf | |
| 01/18/2008 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019847s041,019857s048lbl.pdf | |
| 06/25/2007 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019847s39lbl.pdf | |
| 11/09/2005 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf | |
| 05/18/2005 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019847s032,019857s038lbl.pdf | |
| 01/07/2005 | SUPPL-30 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s035,20780s016lbl.pdf | |
| 07/14/2004 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf | |
| 07/14/2004 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf | |
| 07/14/2004 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf | |
| 03/25/2004 | SUPPL-27 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847se5-027,20780se5-013_cipro_lbl.pdf | |
| 04/17/2002 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf | |
| 08/30/2000 | SUPPL-24 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf |