throbber
FDA Orange Book - Fexofenadine
`
`2/26/2018
`
`Mkt.Status Active Ingredient
`DISCN
`FEXOFENADINE HYDROCHLORIDE
`DISCN
`FEXOFENADINE HYDROCHLORIDE
`RX
`FEXOFENADINE HYDROCHLORIDE
`RX
`FEXOFENADINE HYDROCHLORIDE
`RX
`FEXOFENADINE HYDROCHLORIDE
`RX
`FEXOFENADINE HYDROCHLORIDE
`RX
`FEXOFENADINE HYDROCHLORIDE
`RX
`FEXOFENADINE HYDROCHLORIDE
`RX
`FEXOFENADINE HYDROCHLORIDE
`RX
`FEXOFENADINE HYDROCHLORIDE
`RX
`FEXOFENADINE HYDROCHLORIDE
`RX
`FEXOFENADINE HYDROCHLORIDE
`RX
`FEXOFENADINE HYDROCHLORIDE
`RX
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE
`RX
`FEXOFENADINE HYDROCHLORIDE
`RX
`FEXOFENADINE HYDROCHLORIDE
`DISCN
`FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
`DISCN
`FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Appl No
`Product Number Dosage Form
`Proprietary Name
`N020625 001
`CAPSULE
`ALLEGRA
`A076169 001
`CAPSULE
`FEXOFENADINE HYDROCHLORIDE
`A076191 001
`TABLET
`FEXOFENADINE HYDROCHLORIDE
`A076191 002
`TABLET
`FEXOFENADINE HYDROCHLORIDE
`A076191 003
`TABLET
`FEXOFENADINE HYDROCHLORIDE
`A076447 001
`TABLET
`FEXOFENADINE HYDROCHLORIDE
`A076447 002
`TABLET
`FEXOFENADINE HYDROCHLORIDE
`A076447 003
`TABLET
`FEXOFENADINE HYDROCHLORIDE
`A076502 001
`TABLET
`FEXOFENADINE HYDROCHLORIDE
`A076502 002
`TABLET
`FEXOFENADINE HYDROCHLORIDE
`A076502 003
`TABLET
`FEXOFENADINE HYDROCHLORIDE
`A077081 001
`TABLET
`FEXOFENADINE HYDROCHLORIDE
`A077081 002
`TABLET
`FEXOFENADINE HYDROCHLORIDE
`A077081 003
`TABLET
`FEXOFENADINE HYDROCHLORIDE
`N020872 007
`TABLET
`ALLEGRA ALLERGY
`N020872 010
`TABLET
`ALLEGRA ALLERGY
`N020872 008
`TABLET
`ALLEGRA HIVES
`N020872 009
`TABLET
`ALLEGRA HIVES
`N020872 005
`TABLET
`CHILDREN'S ALLEGRA ALLERGY
`N020872 006
`TABLET
`CHILDREN'S ALLEGRA HIVES
`A076502 004
`TABLET
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
`A076502 005
`TABLET
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
`A076502 006
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`A076502 008
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`A076502 007
`TABLET
`FEXOFENADINE HYDROCHLORIDE HIVES
`A076502 009
`TABLET
`FEXOFENADINE HYDROCHLORIDE HIVES
`A076447 004
`TABLET
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
`A076447 005
`TABLET
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
`A076447 006
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`A076447 008
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`A076447 007
`TABLET
`FEXOFENADINE HYDROCHLORIDE HIVES
`A076447 009
`TABLET
`FEXOFENADINE HYDROCHLORIDE HIVES
`A077081 004
`TABLET
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
`A077081 005
`TABLET
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
`A077081 006
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`A077081 008
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`A077081 007
`TABLET
`FEXOFENADINE HYDROCHLORIDE HIVES
`A077081 009
`TABLET
`FEXOFENADINE HYDROCHLORIDE HIVES
`A091567 002
`TABLET
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
`A091567 001
`TABLET
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
`A091567 004
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`A091567 006
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`A091567 003
`TABLET
`FEXOFENADINE HYDROCHLORIDE HIVES
`A091567 005
`TABLET
`FEXOFENADINE HYDROCHLORIDE HIVES
`A079112 002
`TABLET
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
`A079112 001
`TABLET
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
`A079112 004
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`A079112 006
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`A079112 003
`TABLET
`FEXOFENADINE HYDROCHLORIDE HIVES
`A079112 005
`TABLET
`FEXOFENADINE HYDROCHLORIDE HIVES
`A202039 001
`TABLET
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
`A202039 002
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`A202039 003
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`A204507 002
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`A204507 003
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`A204507 004
`TABLET
`FEXOFENADINE HYDROCHLORIDE HIVES
`A204507 005
`TABLET
`FEXOFENADINE HYDROCHLORIDE HIVES
`A204097 001
`TABLET
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
`A204097 002
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`A204097 003
`TABLET
`FEXOFENADINE HYDROCHLORIDE ALLERGY
`N021909 002
`TABLET, ORALLY DISINTEGRATING
`CHILDREN'S ALLEGRA ALLERGY
`N021909 003
`TABLET, ORALLY DISINTEGRATING
`CHILDREN'S ALLEGRA HIVES
`A202978 001
`TABLET, ORALLY DISINTEGRATING
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
`A202978 002
`TABLET, ORALLY DISINTEGRATING
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
`N201373 001
`SUSPENSION
`CHILDREN'S ALLEGRA ALLERGY
`N201373 002
`SUSPENSION
`CHILDREN'S ALLEGRA HIVES
`A203330 001
`SUSPENSION
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
`A203330 002
`SUSPENSION
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
`A208123 001
`SUSPENSION
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
`A208123 002
`SUSPENSION
`CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
`N021963 001
`SUSPENSION
`ALLEGRA
`A201311 001
`SUSPENSION
`FEXOFENADINE HYDROCHLORIDE
`FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HA076236 001
`TABLET, EXTENDED RELEASE
`FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HA076298 001
`TABLET, EXTENDED RELEASE
`ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
`N020786 002
`TABLET, EXTENDED RELEASE
`
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`
`Approval Date
`TE Code RLD RS Applicant Holder
`Route Strength
`Jul 25, 1996
`ORAL 60MG **Federal Register determinaSANOFI AVENTIS US LLC
`Jul 13, 2005
`ORAL 60MG
`BARR LABORATORIES INC
`Aug 31, 2005
`ORAL 30MG
`BARR LABORATORIES INC
`Aug 31, 2005
`ORAL 60MG
`BARR LABORATORIES INC
`Aug 31, 2005
`ORAL 180MG
`BARR LABORATORIES INC
`Sep 1, 2005
`ORAL 30MG
`TEVA PHARMACEUTICALS USA INC
`Sep 1, 2005
`ORAL 60MG
`TEVA PHARMACEUTICALS USA INC
`Sep 1, 2005
`ORAL 180MG
`TEVA PHARMACEUTICALS USA INC
`Apr 11, 2006
`ORAL 30MG
`DR REDDYS LABORATORIES LTD
`Apr 11, 2006
`ORAL 60MG
`DR REDDYS LABORATORIES LTD
`Apr 11, 2006
`ORAL 180MG
`DR REDDYS LABORATORIES LTD
`Apr 16, 2007
`ORAL 180MG
`MYLAN PHARMACEUTICALS INC
`Apr 11, 2008
`ORAL 30MG
`MYLAN PHARMACEUTICALS INC
`Apr 11, 2008
`ORAL 60MG
`MYLAN PHARMACEUTICALS INC
`Jan 24, 2011
`ORAL 60MG
`SANOFI AVENTIS US LLC
`RLD
`Jan 24, 2011
`ORAL 180MG
`RLD RS SANOFI AVENTIS US LLC
`Jan 24, 2011
`ORAL 60MG
`RLD
`SANOFI AVENTIS US LLC
`Jan 24, 2011
`ORAL 180MG
`RLD RS SANOFI AVENTIS US LLC
`Jan 24, 2011
`ORAL 30MG
`RLD
`SANOFI AVENTIS US LLC
`Jan 24, 2011
`ORAL 30MG
`RLD
`SANOFI AVENTIS US LLC
`Apr 12, 2011
`ORAL 30MG
`DR REDDYS LABORATORIES LTD
`Apr 12, 2011
`ORAL 30MG
`DR REDDYS LABORATORIES LTD
`Apr 12, 2011
`ORAL 60MG
`DR REDDYS LABORATORIES LTD
`Apr 12, 2011
`ORAL 180MG
`DR REDDYS LABORATORIES LTD
`Apr 12, 2011
`ORAL 60MG
`DR REDDYS LABORATORIES LTD
`Apr 12, 2011
`ORAL 180MG
`DR REDDYS LABORATORIES LTD
`Apr 13, 2011
`ORAL 30MG
`TEVA PHARMACEUTICALS USA INC
`Apr 13, 2011
`ORAL 30MG
`TEVA PHARMACEUTICALS USA INC
`Apr 13, 2011
`ORAL 60MG
`TEVA PHARMACEUTICALS USA INC
`Apr 13, 2011
`ORAL 180MG
`TEVA PHARMACEUTICALS USA INC
`Apr 13, 2011
`ORAL 60MG
`TEVA PHARMACEUTICALS USA INC
`Apr 13, 2011
`ORAL 180MG
`TEVA PHARMACEUTICALS USA INC
`Jul 21, 2011
`ORAL 30MG
`MYLAN PHARMACEUTICALS INC
`Jul 21, 2011
`ORAL 30MG
`MYLAN PHARMACEUTICALS INC
`Jul 21, 2011
`ORAL 60MG
`MYLAN PHARMACEUTICALS INC
`Jul 21, 2011
`ORAL 180MG
`MYLAN PHARMACEUTICALS INC
`Jul 21, 2011
`ORAL 60MG
`MYLAN PHARMACEUTICALS INC
`Jul 21, 2011
`ORAL 180MG
`MYLAN PHARMACEUTICALS INC
`Feb 6, 2012
`ORAL 30MG
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Feb 6, 2012
`ORAL 30MG
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Feb 6, 2012
`ORAL 60MG
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Feb 6, 2012
`ORAL 180MG
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Feb 6, 2012
`ORAL 60MG
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Feb 6, 2012
`ORAL 180MG
`SUN PHARMACEUTICAL INDUSTRIES LTD
`Feb 8, 2012
`ORAL 30MG
`WOCKHARDT LTD
`Feb 8, 2012
`ORAL 30MG
`WOCKHARDT LTD
`Feb 8, 2012
`ORAL 60MG
`WOCKHARDT LTD
`Feb 8, 2012
`ORAL 180MG
`WOCKHARDT LTD
`Feb 8, 2012
`ORAL 60MG
`WOCKHARDT LTD
`Feb 8, 2012
`ORAL 180MG
`WOCKHARDT LTD
`Nov 19, 2014
`ORAL 30MG
`AUROLIFE PHARMA LLC
`Nov 19, 2014
`ORAL 60MG
`AUROLIFE PHARMA LLC
`Nov 19, 2014
`ORAL 180MG
`AUROLIFE PHARMA LLC
`Sep 16, 2015
`ORAL 60MG
`SCIEGEN PHARMACEUTICALS INC
`Sep 16, 2015
`ORAL 180MG
`SCIEGEN PHARMACEUTICALS INC
`Sep 16, 2015
`ORAL 60MG
`SCIEGEN PHARMACEUTICALS INC
`Sep 16, 2015
`ORAL 180MG
`SCIEGEN PHARMACEUTICALS INC
`Aug 19, 2016
`ORAL 30MG
`HETERO LABS LTD UNIT V
`Aug 19, 2016
`ORAL 60MG
`HETERO LABS LTD UNIT V
`Aug 19, 2016
`ORAL 180MG
`HETERO LABS LTD UNIT V
`Jan 24, 2011
`ORAL 30MG
`RLD RS SANOFI AVENTIS US LLC
`Jan 24, 2011
`ORAL 30MG
`RLD RS SANOFI AVENTIS US LLC
`Jan 18, 2013
`ORAL 30MG
`DR REDDYS LABORATORIES LTD
`Jan 18, 2013
`ORAL 30MG
`DR REDDYS LABORATORIES LTD
`Jan 24, 2011
`ORAL 30MG/5ML
`RLD RS SANOFI AVENTIS US LLC
`Jan 24, 2011
`ORAL 30MG/5ML
`RLD RS SANOFI AVENTIS US LLC
`Nov 18, 2014
`ORAL 30MG/5ML
`ACTAVIS MID ATLANTIC LLC
`Nov 18, 2014
`ORAL 30MG/5ML
`ACTAVIS MID ATLANTIC LLC
`ORAL 30MG/5ML
`TARO PHARMACEUTICAL INDUSTRIES LTD Nov 9, 2017
`ORAL 30MG/5ML
`TARO PHARMACEUTICAL INDUSTRIES LTD Nov 9, 2017
`ORAL 30MG/5ML
`RLD RS SANOFI AVENTIS US LLC
`Oct 16, 2006
`ORAL 30MG/5ML
`ACTAVIS MID ATLANTIC LLC
`Jul 25, 2012
`ORAL 60MG; 120MG
`BARR LABORATORIES INC
`Apr 14, 2005
`ORAL 60MG; 120MG
`IMPAX PHARMACEUTICALS
`Nov 12, 2010
`ORAL 60MG; 120MG
`RLD RS SANOFI AVENTIS US LLC
`Jan 24, 2011
`
`AB
`AB
`
`Exhibit 1063
`IPR2017-00807
`ARGENTUM
`
`Page 1 of 2
`
`000001
`
`

`

`FDA Orange Book - Fexofenadine
`
`2/26/2018
`
`Mkt.Status Active Ingredient
`OTC
`FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
`OTC
`FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Appl No
`Product Number Dosage Form
`Proprietary Name
`N021704 002
`TABLET, EXTENDED RELEASE
`ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
`FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HA079043 002
`TABLET, EXTENDED RELEASE
`FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HA076667 001
`TABLET, EXTENDED RELEASE
`FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HA090818 001
`TABLET, EXTENDED RELEASE
`FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HA209116 001
`TABLET, EXTENDED RELEASE
`
`Route Strength
`ORAL 180MG; 240MG
`ORAL 180MG; 240MG
`ORAL 60MG; 120MG
`ORAL 60MG; 120MG
`ORAL 60MG; 120MG
`
`TE Code RLD RS Applicant Holder
`RLD RS SANOFI AVENTIS US LLC
`DR REDDYS LABORATORIES LTD
`DR REDDYS LABORATORIES LTD
`SUN PHARMA GLOBAL FZE
`AUROBINDO PHARMA LTD
`
`Approval Date
`Jan 24, 2011
`Jun 22, 2011
`Nov 18, 2014
`Jan 29, 2015
`Oct 30, 2017
`
`https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm
`
`Page 2 of 2
`
`000002
`
`

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