Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021473
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HYDROCHLORIDE 212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None No No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HYDROCHLORIDE 425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None No No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
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-Package Insert, Labeling-Medication Guide 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021473s028lbl.pdf
02/25/2011 SUPPL-28 Labeling-Medication Guide 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

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