Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020786
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60MG;120MG 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
12/24/1997 ORIG-1 Approval Type 4 - New Combination STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020786_allegra-d_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2016 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

10/31/2016 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/02/2016 SUPPL-35 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
07/09/2015 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/08/2015 SUPPL-33 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
05/14/2014 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/05/2012 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020786Orig1s031ltr.pdf
08/23/2012 SUPPL-29 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020786Orig1s029ltr(r).pdf
02/03/2012 SUPPL-28 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-27 Efficacy-Rx To OTC Switch Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020786Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020786s027ltr.pdf
04/14/2010 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020786s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020786s026ltr.pdf
12/06/2004 SUPPL-17 Labeling

Label is not available on this site.

05/12/2003 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20786se8-014,20872se8-011,20625se8-012ltr.pdf
10/31/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/2002 SUPPL-12 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20786slr012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020786_S012_ALLEGRA D.pdf
10/29/2002 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/19/2001 SUPPL-9 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020786_s009_ALLEGRA D.pdf
09/26/2000 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/06/2000 SUPPL-6 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020786_s006_ALLEGRA CAPSULES.pdf
12/01/1999 SUPPL-5 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020786_s005_ALLEGRA D.pdf
01/21/2000 SUPPL-4 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020786_s004_ALLEGRA CAPSULES.pdf
12/22/1998 SUPPL-3 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020786_s003_ALLEGRA TABS.pdf
12/21/1999 SUPPL-2 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020786_s002_ALLEGRA D.pdf
07/06/1998 SUPPL-1 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020786_s001_ALLEGRA TABS.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/02/2016 SUPPL-35 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020786Origs035,021704Orig1s018lbl.pdf
06/08/2015 SUPPL-33 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033, 021704Orig1s017lbl.pdf
12/05/2012 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s031lbl.pdf
08/23/2012 SUPPL-29 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s029lbl.pdf
01/24/2011 SUPPL-27 Efficacy-Rx To OTC Switch Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020786Orig1s027lbl.pdf
04/14/2010 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020786s026lbl.pdf
05/12/2003 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf

ALLEGRA-D 12 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; 60MG;120MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 020786 SANOFI AVENTIS US
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 209116 AUROBINDO PHARMA LTD
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 076667 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 090818 SUN PHARMA GLOBAL

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