Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021277
Company: BAYER HLTHCARE
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HYDROCHLORIDE | 400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 05/06/2020 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021277Orig1s062,021085Orig1s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021277Orig1s062, 021085Orig1s066ltr.pdf | |
| 05/03/2019 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021085s065,021277s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021085Orig1s065, 021277Orig1s061ltr.pdf | |
| 10/18/2018 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021085s064,021277s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021085Orig1s064,021277Orig1s060ltr.pdf | |
| 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) |
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/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-Medication Guide, Labeling-Package Insert |
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 | Labeling, REMS-Proposal |
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 |
|---|---|---|---|---|---|
| 05/06/2020 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021277Orig1s062,021085Orig1s066lbl.pdf | |
| 05/03/2019 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021085s065,021277s061lbl.pdf | |
| 10/18/2018 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021085s064,021277s060lbl.pdf | |
| 09/27/2016 | 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/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-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s047,021277s041lbl.pdf | |
| 02/25/2011 | SUPPL-41 | Labeling-Package Insert | 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 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s042,021277s036lbl.pdf | |
| 04/27/2009 | SUPPL-36 | REMS-Proposal | 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 |