Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021909
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S ALLEGRA ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
CHILDREN'S ALLEGRA HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET, ORALLY DISINTEGRATING;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
07/26/2007 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021909lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021909s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021909_allegra_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/05/2016 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/01/2016 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/10/2016 SUPPL-10 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021909Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021909Orig1s010ltr.pdf
12/09/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/31/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/28/2013 SUPPL-7 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021909Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021909Orig1s007ltr.pdf
08/23/2012 SUPPL-6 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021909Orig1s006ltr.pdf
01/24/2011 SUPPL-3 Efficacy-Rx To OTC Switch Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021909Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021909s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/10/2016 SUPPL-10 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021909Orig1s010lbl.pdf
04/28/2013 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021909Orig1s007lbl.pdf
01/24/2011 SUPPL-3 Efficacy-Rx To OTC Switch Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021909Orig1s003lbl.pdf
07/26/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021909lbl.pdf

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