Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211356

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LEVETIRACETAM IN SODIUM CHLORIDE (LEVETIRACETAM)
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: A211356
Product Number: 001
Approval Date: Feb 12, 2024
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LEVETIRACETAM IN SODIUM CHLORIDE (LEVETIRACETAM)
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: A211356
Product Number: 002
Approval Date: Feb 12, 2024
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LEVETIRACETAM IN SODIUM CHLORIDE (LEVETIRACETAM)
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: A211356
Product Number: 003
Approval Date: Feb 12, 2024
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information