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New Drug Application (NDA): 020872
Company: CHATTEM SANOFI
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALLEGRA ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter None Yes No
ALLEGRA ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter None Yes Yes
ALLEGRA HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Discontinued None Yes No
ALLEGRA HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter None Yes Yes
CHILDREN'S ALLEGRA ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
CHILDREN'S ALLEGRA HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET;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
02/25/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20872lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20872ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-872_Allegra.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/01/2023 SUPPL-47 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020872Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020872Orig1s047ltr.pdf
10/13/2021 SUPPL-46 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020872s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020872Orig1s046ltr.pdf
05/10/2016 SUPPL-38 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020872Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020872Orig1s038ltr.pdf
03/23/2016 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

09/18/2015 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/24/2015 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/02/2014 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

09/12/2014 SUPPL-32 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020872Orig1s032ltr.pdf
04/16/2014 SUPPL-31 Manufacturing (CMC) Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s031bl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020872Orig1s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020872Orig1s031.pdf
04/16/2013 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

08/23/2012 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020872Orig1s029ltr.pdf
02/23/2012 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020872s025ltr.pdf
01/24/2011 SUPPL-23 Efficacy-Rx To OTC Switch Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020872Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020872s023ltr.pdf
06/25/2008 SUPPL-18 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
10/13/2005 SUPPL-15 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020872s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020872s015ltr.pdf
05/12/2003 SUPPL-11 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
10/10/2002 SUPPL-10 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s010_ALLEGRA_TABLETS.pdf
12/10/2002 SUPPL-9 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s009_ALLEGRA_TABLETS.pdf
02/20/2002 SUPPL-8 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s008_ALLEGRA_TABLETS.pdf
07/11/2001 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20625s11ltr.pdf
01/05/2001 SUPPL-5 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020872_s005_ALLEGRA_TABLETS.pdf
05/30/2001 SUPPL-4 Manufacturing (CMC)-Control Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf
05/12/2003 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-003,20625se8-010_allegra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20872se8-003,20625se8-010ltr.pdf
03/21/2000 SUPPL-2 Manufacturing (CMC)-Packaging Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf
04/14/2000 SUPPL-1 Manufacturing (CMC) Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/01/2023 SUPPL-47 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020872Orig1s047lbl.pdf
10/13/2021 SUPPL-46 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020872s046lbl.pdf
05/10/2016 SUPPL-38 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020872Orig1s038lbl.pdf
09/12/2014 SUPPL-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s032lbl.pdf
04/16/2014 SUPPL-31 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s031bl.pdf
08/23/2012 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s029lbl.pdf
02/23/2012 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s025lbl.pdf
01/24/2011 SUPPL-23 Efficacy-Rx To OTC Switch Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020872Orig1s023lbl.pdf
06/25/2008 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.pdf
10/13/2005 SUPPL-15 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020872s015lbl.pdf
05/12/2003 SUPPL-11 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
05/12/2003 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-003,20625se8-010_allegra_lbl.pdf
02/25/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20872lbl.pdf

ALLEGRA ALLERGY

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

TABLET;ORAL; 60MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALLEGRA ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter Yes 020872 CHATTEM SANOFI
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 212971 L PERRIGO CO
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 202039 AUROBINDO PHARMA LTD
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 211075 GRANULES
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 204097 HETERO LABS LTD V
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 077081 RISING
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 204507 SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 076447 TEVA
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 077081 RISING
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 204507 SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 076447 TEVA
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT

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

TABLET;ORAL; 180MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALLEGRA ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter Yes 020872 CHATTEM SANOFI
ALLEGRA HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter Yes 020872 CHATTEM SANOFI
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 212971 L PERRIGO CO
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 202039 AUROBINDO PHARMA LTD
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 211075 GRANULES
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 204097 HETERO LABS LTD V
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 077081 RISING
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 204507 SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076447 TEVA
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 210137 UNIQUE
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 077081 RISING
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 204507 SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076447 TEVA
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT

ALLEGRA HIVES

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

TABLET;ORAL; 180MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALLEGRA ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter Yes 020872 CHATTEM SANOFI
ALLEGRA HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter Yes 020872 CHATTEM SANOFI
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 212971 L PERRIGO CO
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 202039 AUROBINDO PHARMA LTD
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 211075 GRANULES
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 204097 HETERO LABS LTD V
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 077081 RISING
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 204507 SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076447 TEVA
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 210137 UNIQUE
FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076502 DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 077081 RISING
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 204507 SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 091567 SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 076447 TEVA
FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET;ORAL Over-the-counter No 079112 WOCKHARDT

CHILDREN'S ALLEGRA ALLERGY

There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.

CHILDREN'S ALLEGRA HIVES

There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.

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