Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022157
Company: CHATTEM SANOFI
Company: CHATTEM SANOFI
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
01/28/2008 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022157lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022157s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022157_xyzal_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022157s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/02/2019 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022064s038,022157s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022064Orig1s038,022157Orig1s020ltr.pdf | |
01/11/2019 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022064s037,022157s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022064Orig1s037,022157Orig1019ltr.pdf | |
04/02/2018 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022157s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022157s018ltr.pdf | |
10/16/2017 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022157s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022157Orig1s017ltr.pdf | |
07/10/2017 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s033,022157s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022064Orig1s033,022157Orig1s016ltr.pdf | |
11/08/2016 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s032_022157s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022064Orig1s032,022157Orig1s015ltr.pdf | |
02/09/2017 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s031,022157s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022064Orig1s031,022157Orig1s014ltr.pdf | |
06/23/2016 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s030,022157s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022064Orig1s030,022157Orig1s013ltr.pdf | |
11/07/2013 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022064s028_022157s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022064Orig1s028,022157Orig1s012ltr.pdf | |
02/14/2014 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/05/2015 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/06/2012 | SUPPL-8 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022064s024,022157s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022064Orig1s024,022157Orig1s008ltr.pdf | |
03/07/2011 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022064s020,022157s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022064s020,022157s007ltr.pdf | |
08/21/2009 | SUPPL-3 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022064s017,022157s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022064s017,022157s003ltr.pdf | |
06/25/2008 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022157s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022157s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/02/2019 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022064s038,022157s020lbl.pdf | |
01/11/2019 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022064s037,022157s019lbl.pdf | |
04/02/2018 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022157s018lbl.pdf | |
10/16/2017 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022157s017lbl.pdf | |
07/10/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s033,022157s016lbl.pdf | |
02/09/2017 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s031,022157s014lbl.pdf | |
11/08/2016 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s032_022157s015lbl.pdf | |
06/23/2016 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s030,022157s013lbl.pdf | |
11/07/2013 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022064s028_022157s012lbl.pdf | |
09/06/2012 | SUPPL-8 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022064s024,022157s008lbl.pdf | |
03/07/2011 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022064s020,022157s007lbl.pdf | |
08/21/2009 | SUPPL-3 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022064s017,022157s003lbl.pdf | |
06/25/2008 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022157s001lbl.pdf | |
01/28/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022157lbl.pdf |