Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021963
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALLEGRA FEXOFENADINE HYDROCHLORIDE 30MG/5ML SUSPENSION;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
10/16/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021963lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021963s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021963TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/25/2008 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021963s002, 020872s018ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/25/2008 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.pdf
10/16/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021963lbl.pdf

ALLEGRA

SUSPENSION;ORAL; 30MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALLEGRA FEXOFENADINE HYDROCHLORIDE 30MG/5ML SUSPENSION;ORAL Prescription Yes AB 021963 SANOFI AVENTIS US
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG/5ML SUSPENSION;ORAL Prescription No AB 201311 ACTAVIS MID ATLANTIC

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