Product Details for ANDA 078869
LEVETIRACETAM (LEVETIRACETAM)
250MG
Marketing Status: Prescription
500MG
Marketing Status: Prescription
750MG
Marketing Status: Prescription
1GM
Marketing Status: Prescription
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: A078869
Product Number: 001
Approval Date: Mar 13, 2009
Applicant Holder Full Name: VIWIT PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
LEVETIRACETAM (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: A078869
Product Number: 001
Approval Date: Mar 13, 2009
Applicant Holder Full Name: VIWIT PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A078869
Product Number: 002
Approval Date: Mar 13, 2009
Applicant Holder Full Name: VIWIT PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
LEVETIRACETAM (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: A078869
Product Number: 002
Approval Date: Mar 13, 2009
Applicant Holder Full Name: VIWIT PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A078869
Product Number: 003
Approval Date: Mar 13, 2009
Applicant Holder Full Name: VIWIT PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
LEVETIRACETAM (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: A078869
Product Number: 003
Approval Date: Mar 13, 2009
Applicant Holder Full Name: VIWIT PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A078869
Product Number: 004
Approval Date: Mar 13, 2009
Applicant Holder Full Name: VIWIT PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: LEVETIRACETAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1GM
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078869
Product Number: 004
Approval Date: Mar 13, 2009
Applicant Holder Full Name: VIWIT PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information