Product Details for ANDA 207160
LEVETIRACETAM IN SODIUM CHLORIDE (LEVETIRACETAM)
500MG/100ML (5MG/ML)
Marketing Status: Prescription
1GM/100ML (10MG/ML)
Marketing Status: Prescription
1.5GM/100ML (15MG/ML)
Marketing Status: Prescription
500MG/100ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: LEVETIRACETAM
Proprietary Name: LEVETIRACETAM IN SODIUM CHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 500MG/100ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A207160
Product Number: 001
Approval Date: Jan 4, 2017
Applicant Holder Full Name: EUGIA PHARMA SPECIALITIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
LEVETIRACETAM IN SODIUM CHLORIDE (LEVETIRACETAM)
Proprietary Name: LEVETIRACETAM IN SODIUM CHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 500MG/100ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A207160
Product Number: 001
Approval Date: Jan 4, 2017
Applicant Holder Full Name: EUGIA PHARMA SPECIALITIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
1GM/100ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: LEVETIRACETAM
Proprietary Name: LEVETIRACETAM IN SODIUM CHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 1GM/100ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A207160
Product Number: 002
Approval Date: Jan 4, 2017
Applicant Holder Full Name: EUGIA PHARMA SPECIALITIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
LEVETIRACETAM IN SODIUM CHLORIDE (LEVETIRACETAM)
Proprietary Name: LEVETIRACETAM IN SODIUM CHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 1GM/100ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A207160
Product Number: 002
Approval Date: Jan 4, 2017
Applicant Holder Full Name: EUGIA PHARMA SPECIALITIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
1.5GM/100ML (15MG/ML)
Marketing Status: Prescription
Active Ingredient: LEVETIRACETAM
Proprietary Name: LEVETIRACETAM IN SODIUM CHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 1.5GM/100ML (15MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A207160
Product Number: 003
Approval Date: Jan 4, 2017
Applicant Holder Full Name: EUGIA PHARMA SPECIALITIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: LEVETIRACETAM IN SODIUM CHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 1.5GM/100ML (15MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A207160
Product Number: 003
Approval Date: Jan 4, 2017
Applicant Holder Full Name: EUGIA PHARMA SPECIALITIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information