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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202543

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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: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N202543
Product Number: 001
Approval Date: Nov 9, 2011
Applicant Holder Full Name: HQ SPECIALTY PHARMA CORP
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: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N202543
Product Number: 002
Approval Date: Nov 9, 2011
Applicant Holder Full Name: HQ SPECIALTY PHARMA CORP
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: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N202543
Product Number: 003
Approval Date: Nov 9, 2011
Applicant Holder Full Name: HQ SPECIALTY PHARMA CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVETIRACETAM IN SODIUM CHLORIDE (LEVETIRACETAM)
250MG/50ML (5MG/ML)
Marketing Status: Discontinued
Active Ingredient: LEVETIRACETAM
Proprietary Name: LEVETIRACETAM IN SODIUM CHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 250MG/50ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202543
Product Number: 004
Approval Date: Dec 14, 2020
Applicant Holder Full Name: HQ SPECIALTY PHARMA CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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