Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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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 "022399."



Active Ingredient: GABAPENTIN ENACARBIL
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: HORIZANT
Applicant: XENOPORT INC
Strength: 600MG
Application Number: N022399
Product Number: 001
Approval Date: Apr 6, 2011
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: GABAPENTIN ENACARBIL
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: HORIZANT
Applicant: XENOPORT INC
Strength: 300MG
Application Number: N022399
Product Number: 002
Approval Date: Dec 13, 2011
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
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 March 01, 2014
Patent and Generic Drug Product Data Last Updated April 18, 2014

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