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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "022115."



Active Ingredient: LAMOTRIGINE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: LAMICTAL XR
Applicant: GLAXOSMITHKLINE LLC
Strength: 25MG
Application Number: N022115
Product Number: 001
Approval Date: May 29, 2009
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: LAMOTRIGINE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: LAMICTAL XR
Applicant: GLAXOSMITHKLINE LLC
Strength: 50MG
Application Number: N022115
Product Number: 002
Approval Date: May 29, 2009
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: LAMOTRIGINE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: LAMICTAL XR
Applicant: GLAXOSMITHKLINE LLC
Strength: 100MG
Application Number: N022115
Product Number: 003
Approval Date: May 29, 2009
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: LAMOTRIGINE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: LAMICTAL XR
Applicant: GLAXOSMITHKLINE LLC
Strength: 200MG
Application Number: N022115
Product Number: 004
Approval Date: May 29, 2009
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: LAMOTRIGINE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: LAMICTAL XR
Applicant: GLAXOSMITHKLINE LLC
Strength: 300MG
Application Number: N022115
Product Number: 005
Approval Date: Apr 14, 2010
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: LAMOTRIGINE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: LAMICTAL XR
Applicant: GLAXOSMITHKLINE LLC
Strength: 250MG
Application Number: N022115
Product Number: 006
Approval Date: Jun 21, 2011
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

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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 August 2014
Patent and Generic Drug Product Data Last Updated October 01, 2014

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