Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022064
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XYZAL LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription AB 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
05/25/2007 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022064s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022064_xyzal_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022064s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/02/2018 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022064s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022064s036ltr.pdf
10/16/2017 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022064Orig1s034ltr.pdf
07/10/2017 SUPPL-33 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-32 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-31 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-30 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-28 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-27 Manufacturing (CMC)

Label is not available on this site.

11/20/2012 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/06/2012 SUPPL-24 Labeling-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-20 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-17 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
03/31/2008 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022064s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022064s009ltr.pdf
02/01/2008 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022064s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022064s005ltr.pdf
10/18/2007 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/02/2018 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022064s036lbl.pdf
10/16/2017 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s034lbl.pdf
07/10/2017 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s033,022157s016lbl.pdf
02/09/2017 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s031,022157s014lbl.pdf
11/08/2016 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s032_022157s015lbl.pdf
06/23/2016 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s030,022157s013lbl.pdf
11/07/2013 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022064s028_022157s012lbl.pdf
09/06/2012 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022064s024,022157s008lbl.pdf
03/07/2011 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022064s020,022157s007lbl.pdf
08/21/2009 SUPPL-17 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022064s017,022157s003lbl.pdf
03/31/2008 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022064s009lbl.pdf
02/01/2008 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022064s005lbl.pdf
05/25/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022064lbl.pdf

XYZAL

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 203027 APOTEX INC
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090392 DR REDDYS LABS LTD
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090385 GLENMARK GENERICS
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091264 HETERO LABS LTD III
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 205564 MACLEODS PHARMS LTD
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202046 MICRO LABS LTD INDIA
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 204323 NEOPHARMA
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 203646 SCIEGEN PHARMS INC
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 201653 SUN PHARM INDS LTD
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090362 SUN PHARMA GLOBAL
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090229 SYNTHON PHARMS
LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090199 TEVA PHARMS
XYZAL LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 022064 SANOFI AVENTIS US

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