Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019857
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER CIPROFLOXACIN 200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER CIPROFLOXACIN 400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
05/03/2019 SUPPL-69 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019857s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019857Orig1s069ltr.pdf
10/18/2018 SUPPL-68 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019857s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019857Orig1s068ltr.pdf
07/26/2017 SUPPL-66 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/2017/019857s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019857Orig1s066ltr.pdf
07/26/2016 SUPPL-65 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019857s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537s086,019847s057,019857s065,020780s043,021473Orig1s037ltr.pdf
03/19/2015 SUPPL-64 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-63 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-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019857s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019857Orig1s062ltr.pdf
10/14/2013 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

01/30/2013 SUPPL-60 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-59 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-58 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s079,019847s051,019857s058,020780s037,021473s032MedG.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s079,019847s051,019857s058,020780s037,021473s032ltr.pdf
08/12/2011 SUPPL-57 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-54 Labeling-Package Insert, 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-53 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-52 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-51 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/2009/019857s051ltr.pdf
02/13/2009 SUPPL-50 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-49 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf
01/18/2008 SUPPL-48 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/2008/019857s048ltr.pdf
06/25/2007 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019857s46lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,19857s46,20780s24,21473s22ltr.pdf
06/19/2006 SUPPL-42 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-41 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/2005/019857_S041_Cipro.pdf
05/18/2005 SUPPL-38 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-36 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/2004/019857_S036_CIPRO.pdf
01/07/2005 SUPPL-35 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-34 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/2004/019857_S034_CIPRO.pdf
07/14/2004 SUPPL-33 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/2004/019857_S033_CIPRO.pdf
03/25/2004 SUPPL-31 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
12/10/2002 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/17/2002 SUPPL-28 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/2002/019857_S028_CIPRO.pdf
08/30/2000 SUPPL-27 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
06/09/1999 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/2000 SUPPL-25 Labeling

Label is not available on this site.

09/24/1998 SUPPL-24 Labeling

Label is not available on this site.

01/07/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/13/1998 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1998 SUPPL-21 Efficacy-New Indication

Label is not available on this site.

09/24/1998 SUPPL-20 Labeling

Label is not available on this site.

09/24/1998 SUPPL-19 Efficacy-New Indication

Label is not available on this site.

08/15/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/07/1997 SUPPL-17 Efficacy-New Indication

Label is not available on this site.

08/09/1996 SUPPL-16 Labeling

Label is not available on this site.

06/28/1996 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/03/1998 SUPPL-14 Efficacy-New Patient Population

Label is not available on this site.

09/26/1997 SUPPL-13 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019857_S013_CIPRO.pdf
10/10/1996 SUPPL-11 Efficacy-New Indication

Label is not available on this site.

04/28/1994 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/27/1993 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1996 SUPPL-8 Efficacy-New Indication

Label is not available on this site.

10/25/1995 SUPPL-6 Labeling

Label is not available on this site.

04/23/1992 SUPPL-5 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.

04/24/1991 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/24/1991 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/03/2019 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019857s069lbl.pdf
10/18/2018 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019857s068lbl.pdf
07/26/2017 SUPPL-66 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/2017/019857s066lbl.pdf
07/26/2016 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019857s065lbl.pdf
03/19/2015 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s056,019857s064lbl.pdf
02/02/2015 SUPPL-63 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s055,019857s063lbl.pdf
08/14/2013 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019857s062lbl.pdf
01/30/2013 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019847s053,019857s060lbl.pdf
11/15/2011 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s046,019857s053lbl.pdf
10/18/2011 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf
08/12/2011 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s050,019857s057lbl.pdf
08/03/2011 SUPPL-58 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s079,019847s051,019857s058,020780s037,021473s032MedG.pdf
02/25/2011 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s047,019857s054lbl.pdf
02/25/2011 SUPPL-54 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s047,019857s054lbl.pdf
04/27/2009 SUPPL-51 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf
04/27/2009 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf
02/13/2009 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27lbl.pdf
10/03/2008 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf
01/18/2008 SUPPL-48 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019847s041,019857s048lbl.pdf
06/25/2007 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019857s46lbl.pdf
11/09/2005 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf
05/18/2005 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019847s032,019857s038lbl.pdf
01/07/2005 SUPPL-35 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s035,20780s016lbl.pdf
07/14/2004 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf
07/14/2004 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf
07/14/2004 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf
03/25/2004 SUPPL-31 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-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf
08/30/2000 SUPPL-27 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf

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