Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021721
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVAQUIN | LEVOFLOXACIN | 250MG/10ML | SOLUTION;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/21/2004 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21721lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21721ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021721s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/08/2017 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020634s068,020635s074,021721s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020634Orig1s068,020635Orig1s074,021721Orig1s035ltr.pdf | |
| 07/26/2016 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020634s067_020635s073_021721Orig1s034ltr.pdf | |
| 05/23/2014 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020634s066,020635s072,021721s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020634Orig1s066,020635Orig1s072,021721Orig1s033ltr.pdf | |
| 08/14/2013 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020634s065,020635s071,021721s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020634Orig1s065,020635Orig1s071,021721Orig1s032ltr_replace.pdf | |
| 10/11/2011 | SUPPL-31 | REMS-Modified |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021721Orig1s029s031.pdf | |
| 10/11/2011 | SUPPL-29 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021721Orig1s029s031.pdf | |
| 04/27/2012 | SUPPL-28 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020634s061,020635s067,021721s028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061, 020635Orig1s067, 021721Orig1s028TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061,%20020635Orig1s067,%20021721Orig1s028SumR.pdf | |
| 06/09/2011 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s059,020635s065,021721s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s059,020635s065,021721s026ltr.pdf | |
| 02/25/2011 | SUPPL-25 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s058,020635s064,021721s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s058,020635s064,021721s025ltr.pdf | |
| 03/12/2009 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s054,020635s059,021721s022ltr.pdf |
| 04/27/2009 | SUPPL-21 | REMS-Proposal, Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020634s053,020635s058, 021721s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s053,020635s058,021721s021lt.pdf | |
| 10/03/2008 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021721s020_020635s57_020634s52_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s052, 020635s057,021721s020ltr .pdf | |
| 04/16/2008 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020634s051,020635s055,021721s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s051, 020635s055, 021721s019ltr.pdf | |
| 12/13/2007 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s050,020635s054,021721s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s050, 020635s054, 021721s018ltr.pdf | |
| 11/16/2007 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s049,020635s053,021721s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s049,020635s053,021721s017ltr.pdf | |
| 11/15/2007 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s048,020635s052,021721s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s048,020635s052,021721s016ltr.pdf | |
| 05/05/2008 | SUPPL-15 | Efficacy-New Patient Population |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634se5-047020635se5-051021721se5-015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020634se5-047,020635se5-051,021721se5-015_SUMR.pdf |
| 06/19/2007 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s045,020635s048,021721s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s045, 020635s048, 021721s013ltr.pdf | |
| 05/10/2007 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s044,020635s047,021721s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s044,020635s047,021721s012ltr.pdf | |
| 09/11/2007 | SUPPL-11 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s043,020635s046,021721s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s043,020635s046,021721s011ltr.pdf | |
| 05/31/2007 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s042,020635s045,021721s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s042,020635s045,021721s010ltr.pdf | |
| 09/14/2007 | SUPPL-9 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s041,020635s044,021721s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s041,020635s044,021721s009ltr.pdf | |
| 06/23/2006 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s040,020635s043,021721s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020634s040,020635s043,021721s007LTR.pdf | |
| 01/20/2006 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s039,020635s042,021721s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021721s006ltr.pdf | |
| 11/24/2004 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s035,20635s035,21721s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s035,20635s035,21721s003ltr.pdf | |
| 08/04/2005 | SUPPL-2 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020634s037,020635s038,021721s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020634s037,020635s038,021721s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/08/2017 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020634s068,020635s074,021721s035lbl.pdf | |
| 07/26/2016 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf | |
| 05/23/2014 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020634s066,020635s072,021721s033lbl.pdf | |
| 08/14/2013 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020634s065,020635s071,021721s032lbl.pdf | |
| 04/27/2012 | SUPPL-28 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028lbl.pdf | |
| 10/11/2011 | SUPPL-31 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf | |
| 10/11/2011 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf | |
| 10/11/2011 | SUPPL-29 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf | |
| 06/09/2011 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s059,020635s065,021721s026lbl.pdf | |
| 02/25/2011 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s058,020635s064,021721s025lbl.pdf | |
| 02/25/2011 | SUPPL-25 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s058,020635s064,021721s025lbl.pdf | |
| 04/27/2009 | SUPPL-21 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020634s053,020635s058, 021721s021lbl.pdf | |
| 04/27/2009 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020634s053,020635s058, 021721s021lbl.pdf | |
| 10/03/2008 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021721s020_020635s57_020634s52_lbl.pdf | |
| 04/16/2008 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020634s051,020635s055,021721s019lbl.pdf | |
| 12/13/2007 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s050,020635s054,021721s018lbl.pdf | |
| 11/16/2007 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s049,020635s053,021721s017lbl.pdf | |
| 11/15/2007 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s048,020635s052,021721s016lbl.pdf | |
| 09/14/2007 | SUPPL-9 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s041,020635s044,021721s009lbl.pdf | |
| 09/11/2007 | SUPPL-11 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s043,020635s046,021721s011lbl.pdf | |
| 06/19/2007 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s045,020635s048,021721s031lbl.pdf | |
| 05/31/2007 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s042,020635s045,021721s010lbl.pdf | |
| 05/10/2007 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s044,020635s047,021721s012lbl.pdf | |
| 06/23/2006 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s040,020635s043,021721s007lbl.pdf | |
| 01/20/2006 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s039,020635s042,021721s006lbl.pdf | |
| 08/04/2005 | SUPPL-2 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020634s037,020635s038,021721s002lbl.pdf | |
| 11/24/2004 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s035,20635s035,21721s003lbl.pdf | |
| 10/21/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21721lbl.pdf |