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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212688

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LEVETIRACETAM (LEVETIRACETAM)
500MG
Marketing Status: Prescription
Active Ingredient: LEVETIRACETAM
Proprietary Name: LEVETIRACETAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212688
Product Number: 002
Approval Date: May 5, 2023
Applicant Holder Full Name: OVERSEAS PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVETIRACETAM (LEVETIRACETAM)
750MG
Marketing Status: Prescription
Active Ingredient: LEVETIRACETAM
Proprietary Name: LEVETIRACETAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 750MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212688
Product Number: 001
Approval Date: Jun 11, 2020
Applicant Holder Full Name: OVERSEAS PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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