Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021277
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER MOXIFLOXACIN HYDROCHLORIDE 400MG/250ML (1.6MG/ML) SOLUTION;IV (INFUSION) Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/30/2001 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21277lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21277_Avelox_Approv.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21277_Avelox.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/26/2016 SUPPL-59 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021277Orig1s059,21085Orig1s063lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021277Orig1s059,21085Orig1s063ltr.pdf
09/27/2016 SUPPL-58 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021085s061s062,021277s057s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021085Orig1s061,s062,021277Orig1s057,s058ltr.pdf
09/27/2016 SUPPL-57 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021085s061s062,021277s057s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021085Orig1s061,s062,021277Orig1s057,s058ltr.pdf
05/08/2015 SUPPL-56 Efficacy-Animal Rule Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021085s060,021277s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021085Origs060,021277Orig1s056ltr.pdf
11/20/2014 SUPPL-55 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021085s059,021277s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021085Orig1s059,021277Orig1s055ltr.pdf
08/14/2013 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021085s057,021277s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021277Orig1s054,021085Orig1s057ltr.pdf
12/18/2012 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021085s056,021277s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021085Orig1s056,021277Orig1s053ltr.pdf
08/24/2012 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021085s55-021277s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021085Orig1s055,021277Orig1s052ltr.pdf
10/18/2011 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s050,s053,021277s046,s050ltr.pdf
08/03/2011 SUPPL-49 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s052,021277s049ltr.pdf
10/18/2011 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s050,s053,021277s046,s050ltr.pdf
02/25/2011 SUPPL-41 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s047,021277s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s047,021277s041ltr.pdf
03/02/2010 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021085s046,021277s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021085s046,021277s040ltr.pdf
11/24/2009 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s045,021277s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s045,021277s039ltr.pdf
10/25/2010 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021277s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021085s044,021277s038ltr.pdf
04/27/2009 SUPPL-36 REMS-Proposal, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s042,021277s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s042,021277s036ltr.pdf
06/24/2009 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s041,021277s035ltr.pdf
10/03/2008 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s040,021277s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021085s040, 021277s034ltr.pdf
12/29/2008 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s039,021277s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021085s039, 021277s033ltr.pdf
02/15/2008 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s038,021277s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021277s031ltr.pdf
05/31/2007 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021085s036,021277s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021085s036,021277s030ltr.pdf
11/22/2005 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s027,029,021277s024,025ltr.pdf
11/22/2005 SUPPL-24 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s027,029,021277s024,025ltr.pdf
06/13/2005 SUPPL-22 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s026,021277s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s026,021277s022ltr.pdf
07/28/2004 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277s019,21085s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21277s019,21085s024ltr.pdf
03/06/2004 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277slr018,21085slr023_avelox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21277slr018,21085slr023ltr.pdf
05/18/2004 SUPPL-17 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21085se1-022,21277se1-017_avelox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21085se1-022,21277se1-017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021277_S017_AVELOX_TABLETS.pdf
10/06/2003 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21277slr011,21085slr019_avelox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21277slr011,21085slr019ltr.pdf
02/28/2003 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf
02/28/2003 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021277_S007_AVELOX.pdf
02/28/2003 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf
12/10/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2002 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21-085s012ltr.pdf
06/12/2002 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s6s7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21085s006ltr.pdf
05/22/2002 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21277s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/27/2016 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021085s061s062,021277s057s058lbl.pdf
09/27/2016 SUPPL-57 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021085s061s062,021277s057s058lbl.pdf
07/26/2016 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021277Orig1s059,21085Orig1s063lbledt.pdf
05/08/2015 SUPPL-56 Efficacy-Animal Rule Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021085s060,021277s056lbl.pdf
11/20/2014 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021085s059,021277s055lbl.pdf
08/14/2013 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021085s057,021277s054lbl.pdf
12/18/2012 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021085s056,021277s053lbl.pdf
08/24/2012 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021085s55-021277s052lbl.pdf
10/18/2011 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf
10/18/2011 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf
02/25/2011 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s047,021277s041lbl.pdf
02/25/2011 SUPPL-41 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s047,021277s041lbl.pdf
10/25/2010 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021277s038lbl.pdf
03/02/2010 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021085s046,021277s040lbl.pdf
11/24/2009 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s045,021277s039lbl.pdf
04/27/2009 SUPPL-36 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s042,021277s036lbl.pdf
04/27/2009 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s042,021277s036lbl.pdf
12/29/2008 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s039,021277s033lbl.pdf
10/03/2008 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s040,021277s034lbl.pdf
02/15/2008 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s038,021277s031lbl.pdf
05/31/2007 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021085s036,021277s030lbl.pdf
11/22/2005 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf
11/22/2005 SUPPL-24 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf
06/13/2005 SUPPL-22 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s026,021277s022lbl.pdf
07/28/2004 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277s019,21085s024lbl.pdf
05/18/2004 SUPPL-17 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21085se1-022,21277se1-017_avelox_lbl.pdf
03/06/2004 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277slr018,21085slr023_avelox_lbl.pdf
10/06/2003 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21277slr011,21085slr019_avelox_lbl.pdf
02/28/2003 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf
02/28/2003 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf
02/28/2003 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf
06/12/2002 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s6s7lbl.pdf
05/16/2002 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s12lbl.pdf
11/30/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21277lbl.pdf

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

SOLUTION;IV (INFUSION); 400MG/250ML (1.6MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER MOXIFLOXACIN HYDROCHLORIDE 400MG/250ML (1.6MG/ML) SOLUTION;IV (INFUSION) Prescription Yes AP 021277 BAYER HLTHCARE
MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER MOXIFLOXACIN HYDROCHLORIDE 400MG/250ML (1.6MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 205833 MYLAN LABS LTD

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