Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021704
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180MG;240MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter None 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
10/19/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21704lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21704ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021704s000_AllegraTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2016 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/02/2016 SUPPL-18 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020786Origs035,021704Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020786Orig1s035,021704Orig1s018ltr.pdf
06/08/2015 SUPPL-17 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033, 021704Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020786Orig1s033,021704Orig1s017ltr.pdf
01/30/2014 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/18/2013 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/06/2014 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/05/2012 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021704s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021704Orig1s013ltr.pdf
08/23/2012 SUPPL-11 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021704Org1s011ltr.pdf
02/03/2012 SUPPL-10 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/20786s028,021704s010ltr.pdf
01/24/2011 SUPPL-8 Efficacy-Rx To OTC Switch Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021704Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021704s008ltr.pdf
04/14/2010 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021704s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021704s007ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/02/2016 SUPPL-18 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020786Origs035,021704Orig1s018lbl.pdf
06/08/2015 SUPPL-17 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033, 021704Orig1s017lbl.pdf
12/05/2012 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021704s013lbl.pdf
01/24/2011 SUPPL-8 Efficacy-Rx To OTC Switch Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021704Orig1s008lbl.pdf
04/14/2010 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021704s007lbl.pdf
10/19/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21704lbl.pdf

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, EXTENDED RELEASE;ORAL; 180MG;240MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180MG;240MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 021704 SANOFI AVENTIS US
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180MG;240MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 079043 DR REDDYS LABS LTD

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