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`E9A Home3 ~rugRa~ases4 OraBgoBook5
`•
`•
`•
`rangeo :pproverug Products w1th Therapeutic Equtvalence
`Evaluations
`S"earch results from the "OB_Rx" table for query on "020272."
`-------·-· -·----·---------·-·-·-------------·-··---·-·
`
`·----·------
`
`Active Ingredient:
`RISPERIDONE
`TABLET;ORAL
`Dosage Form;Route:
`RISPERDAL
`Proprietary Name:
`JANSSEN PHARMS
`Applicant:
`1MG
`Strength:
`N020272
`Application Number:
`Product Number:
`001
`Approval Date:
`Dec 29, 1993
`Reference Listed Drug
`Yes
`RX
`RX/OTC/DISCN:
`AB
`TE Code:
`Patent and Exclusivity Info for this product: View
`
`RISPERIDONE
`Active Ingredient:
`TABLET;ORAL
`Dosage Form;Route:
`RISPERDAL
`Proprietary Name:
`JANSSEN PHARMS
`Applicant:
`2MG
`Strength:
`N020272
`Application Number:
`002
`Product Number:
`Dec 29, 1993
`Approval Date:
`No
`Reference Listed Drug
`RX
`RX/OTC/DISCN:
`AB
`TE Code:
`Patent and Exclusivity Info for this product: View
`
`RISPERIDONE
`Active Ingredient:
`TABLET;ORAL
`Dosage Form;Route:
`RISPERDAL
`Proprietary Name:
`JANSSEN PHARMS
`Applicant:
`3MG
`Strength:
`N020272
`Application Number:
`003
`Product Number:
`Dec 29, 1993
`Approval Date:
`No
`Reference Listed Drug
`RX
`RX/OTC/DISCN:
`AB
`TE Code:
`Patent and Exclusivity Info for this product: View
`
`Active Ingredient:
`Dosage Form; Route:
`
`RISPERIDONE
`TABLET; ORAL
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm? Appl_ No=020272&TAB... 5/31/2016
`
`LUYE1023
`IPR of Patent No. 6,667,061
`
`Page 1 of 5
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 2 of3
`
`Proprietary Name:
`RISPERDAL
`Applicant:
`JANSSEN PHARMS
`Strength:
`4MG
`Application Number:
`N020272
`Product Number:
`004
`Approval Date:
`Dec 29, 1993
`Reference Listed Drug
`No
`RX/OTC/DISCN:
`RX
`AB
`TE Code:
`Patent and Exclusivity Info for this product: View
`
`Active Ingredient:
`RISPERIDONE
`Dosage Form;Route:
`TABLET;ORAL
`Proprietary Name:
`RISPERDAL
`Applicant:
`JANSSEN PHARMS
`Strength:
`O.SMG
`Application Number:
`N020272
`Product Number:
`007
`Approval Date:
`Jan 27, 1999
`Reference Listed Drug
`No
`RX/OTC/DISCN:
`RX
`AB
`TE Code:
`Patent and Exclusivity Info for this product: View
`
`Active Ingredient:
`RISPERIDONE
`Dosage Form;Route:
`TABLET;ORAL
`Proprietary Name:
`RISPERDAL
`Applicant:
`JANSSEN PHARMS
`Strength:
`0.25MG
`Application Number:
`N020272
`Product Number:
`008
`Approval Date:
`May 10, 1999
`Reference Listed Drug
`No
`RX/OTC/DISCN:
`RX
`AB
`TE Code:
`Patent and Exclusivity Info for this product: View
`
`Return to Electronic Orange Book Home Page6
`
`FDA/Center for Drug Evaluation and Research
`Office of Generic Drugs
`Division of Labeling and Program Support
`Update Frequency:
`Orange Book Data - Monthly
`Generic Drug Product Information & Patent Information - Daily
`Orange Book Data Updated Through April 2016
`Patent and Generic Drug Product Data Last Updated May 31, 2016
`
`Links on this page:
`1. http://www .addthis.com/bookmark. php?
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm? Appl_ No=020272&TAB... 5/31/2016
`
`LUYE1023
`IPR of Patent No. 6,667,061
`
`Page 2 of 5
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 3 of3
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`u508=true&v= 152&username=fdamain
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`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm? Appl_No=020272&TAB... 5/31/2016
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`LUYE1023
`IPR of Patent No. 6,667,061
`
`Page 3 of 5
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 1 of2
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`E9A Home3 ~r~Ra~ases4 Oraagr.,Book5
`•
`•
`•
`rangeo :pproverug Products w1th Therapeutic Equivalence
`Evaluations
`S"earch results from the "OB_Rx" table for query on "020588."
`----------------
`
`Active Ingredient:
`RISPERIDONE
`Dosage Form;Route:
`SOLUTION ;ORAL
`Proprietary Name:
`RISPERDAL
`JANSSEN PHARMS
`Applicant:
`Strength:
`1MG/ML
`Application Number:
`N020588
`001
`Product Number:
`Approval Date:
`Jun 10, 1996
`Yes
`Reference Listed Drug
`RX
`RX/OTC/DISCN:
`AA
`TE Code:
`Patent and Exclusivity Info for this product: View
`
`Return to Electronic Orange Book Home Page6
`
`FDA/Center for Drug Evaluation and Research
`Office of Generic Drugs
`Division of Labeling and Program Support
`Update Frequency:
`Orange Book Data - Monthly
`Generic Drug Product Information & Patent Information - Daily
`Orange Book Data Updated Through April 2016
`Patent and Generic Drug Product Data Last Updated May 31, 2016
`
`Links on this page:
`1. http://www .addthis.com/bookmark.php?
`u508=true&v= 152&username=fdamain
`2. http://www .addthis.com/bookmark. php
`3. http://www.fda.gov/default.htm
`4. http://www. fda.gov /Drugs/InformationOnDrugs/default. htm
`5.
`../default.cfm
`6.
`../default.cfm
`
`Note: If you need help accessing information in different file formats, see Instructions for
`Downloading Viewers and Players.
`Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Transparency
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`I
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`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm? Appl_ No=020588&TAB... 5/31/2016
`
`LUYE1023
`IPR of Patent No. 6,667,061
`
`Page 4 of 5
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 2 of2
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Contact FDA
`Ill
`,•tfs" .
`><~\t90i ...
`For Government For Press
`Combination Products Advisory Committees Science & Research Regulatory Information Safety
`Emergency Preparedness International Programs News & Events Training and Continuing
`Education Inspections/Compliance State & Local Officials Consumers Industry Health
`Professionals FDA Archive
`
`4 u.s. Department of Hea1th & Human ~rvices
`
`Links on this page:
`
`1.
`
`http://www .accessdata.fda.gov /scripts/cder/ob/docs/obdetail.cfm? Appl_ No=0205 88&T AB... 5/31/2016
`
`LUYE1023
`IPR of Patent No. 6,667,061
`
`Page 5 of 5