Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022157
Company: SANOFI-AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XYZAL LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION;ORAL Prescription AA 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
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
04/02/2018 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
04/02/2018 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

XYZAL

SOLUTION;ORAL; 2.5MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION;ORAL Prescription No AA 202915 APOTEX INC
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION;ORAL Prescription No AA 091263 L PERRIGO CO
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION;ORAL Prescription No AA 204599 SILARX PHARMS INC
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION;ORAL Prescription No AA 202673 TARO PHARM INDS
XYZAL LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION;ORAL Prescription Yes AA 022157 SANOFI-AVENTIS US

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