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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022285

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KEPPRA XR (LEVETIRACETAM)
500MG
Marketing Status: Prescription
Active Ingredient: LEVETIRACETAM
Proprietary Name: KEPPRA XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022285
Product Number: 001
Approval Date: Sep 12, 2008
Applicant Holder Full Name: UCB INC
Marketing Status:  Prescription
Patent and Exclusivity Information
KEPPRA XR (LEVETIRACETAM)
750MG
Marketing Status: Prescription
Active Ingredient: LEVETIRACETAM
Proprietary Name: KEPPRA XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 750MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022285
Product Number: 002
Approval Date: Feb 12, 2009
Applicant Holder Full Name: UCB INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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