Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078042

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LEVETIRACETAM (LEVETIRACETAM)
250MG
Marketing Status: Prescription

Active Ingredient: LEVETIRACETAM
Proprietary Name: LEVETIRACETAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078042
Product Number: 001
Approval Date: Jan 15, 2009
Applicant Holder Full Name: ACI HEALTHCARE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LEVETIRACETAM (LEVETIRACETAM)
500MG
Marketing Status: Prescription

Active Ingredient: LEVETIRACETAM
Proprietary Name: LEVETIRACETAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078042
Product Number: 002
Approval Date: Jan 15, 2009
Applicant Holder Full Name: ACI HEALTHCARE 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; ORAL
Strength: 750MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078042
Product Number: 003
Approval Date: Jan 15, 2009
Applicant Holder Full Name: ACI HEALTHCARE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LEVETIRACETAM (LEVETIRACETAM)
1GM
Marketing Status: Prescription

Active Ingredient: LEVETIRACETAM
Proprietary Name: LEVETIRACETAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1GM
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078042
Product Number: 004
Approval Date: Jan 15, 2009
Applicant Holder Full Name: ACI HEALTHCARE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information