Health 3; Human Services
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`Orange Book: Approved Drug Products with Therapeutic
`Equivalence Evaluations
`D FDA Home 0 Drug Database; 0 Orange Book
`Search restita from the '0B_Rx" table for queryI on "020241."
`
`I. n
`
`LAMOTRIGINE
`Active Ingredient:
`TABLET,0RAL
`Dosage Form,Route
`LAMICTAL
`Proprietary Name:
`GLAXOSMITHKLINE LLC
`Applicant:
`100MG
`Strength:
`N020241
`Application Number:
`001
`Product Number:
`Dec 2?, 1994
`Approval Date:
`No
`Relerenoe Usted Drug
`RX
`RXJDTCIDISCN'
`AB
`TE Code
`Patent and Exclusivity Into tor this product: View
`
`LAMOTRIGINE
`Active Ingredient:
`TABLET;ORAL
`Dosage Form;Route
`LAMICTAL
`Proprietary Name:
`GLAXOSMITHKLINE LLC
`Applimnt:
`150MG
`Strengm:
`N020241
`Application Number:
`002
`Product Number.
`Dec 2?. 1994
`Approval Date:
`No
`Reterenoe Usted Drug
`RX
`RXJDTCIDISCN:
`AB
`TE Code
`Patent and Exclusivity Into tor this product: View
`
`LAMOTRIGINE
`Active Ingredient:
`TABLET;0RAL
`Dosage Form;Route
`LAMICTAL
`Proprietary Name:
`GLAXOSMITHKLINE LLC
`Applicant
`200MG
`Strength.
`N020241
`Application Number:
`003
`Product Number:
`Dec 2?, 1994
`Approval Date:
`No
`Reterenoe Usted Drug
`RX
`RXJDTCIDISCN:
`AB
`TE Code
`Patent and Exclusivity Into tor this product. View
`
`LAMOTRIGINE
`Active Ingredient:
`TABLET;ORAL
`Dosage Form;Route
`LAMICTAL
`Proprietary Name:
`GLAXOSMITHKLINE LLC
`Applicant:
`25MG
`Strength:
`N020241
`Application Number:
`005
`Product Number:
`Dec 2?, 1994
`Approval Date:
`Yes
`Reference ljsted Drug
`RX
`RXJDTCIDISCN.
`AB
`TE Code
`Patent and Exclusivity Into tor this product: View
`
`Return to FJectronic Orange Book Home Page
`
`FDAJCenter tor Drug Evaluation and Research
`Otioe otGeneric Drugs
`Division of Labeling and Program Support
`Update Frequency
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`
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`_http_://ww_w.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?App|_No=020241&TABLE1=OB_Rx
`
`Actavis v. Research Corp. Techs.
`|PR2014-01126
`
`RCT EX. 2007 page 1
`
`Actavis v. Research Corp. Techs.
`IPR2014-01126
`RCT EX. 2007 page 1
`
`

`

`Olioe of Genem Drugs
`Division of Labeling and Program Support
`Update Frequency:
`Orange Book Data — Hmifly
`Genem Drug Product hiormaion 8. Patent hiormaion — Daiy
`Orange Book Data Updated Through AugustQflM
`Paientand Genem Drug Product Data Last Updated Oclober 10, 2014
`
`Note: liyou need help accessing iniormaion in difierentile formats, see Inslruclions for Downloading Viewers and Players.
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`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?App|_No=020241&TABLE1=OB_Rx
`
`Actavis v. Research Corp. Techs.
`|PR2014-01126
`
`RCT EX. 2007 page 2
`
`Actavis v. Research Corp. Techs.
`IPR2014-01126
`RCT EX. 2007 page 2
`
`