Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207958

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SPRITAM (LEVETIRACETAM)
250MG
Marketing Status: Prescription

Active Ingredient: LEVETIRACETAM
Proprietary Name: SPRITAM
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 250MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207958
Product Number: 001
Approval Date: Jul 31, 2015
Applicant Holder Full Name: APRECIA PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SPRITAM (LEVETIRACETAM)
500MG
Marketing Status: Prescription

Active Ingredient: LEVETIRACETAM
Proprietary Name: SPRITAM
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207958
Product Number: 002
Approval Date: Jul 31, 2015
Applicant Holder Full Name: APRECIA PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SPRITAM (LEVETIRACETAM)
750MG
Marketing Status: Discontinued

Active Ingredient: LEVETIRACETAM
Proprietary Name: SPRITAM
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 750MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207958
Product Number: 003
Approval Date: Jul 31, 2015
Applicant Holder Full Name: APRECIA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

SPRITAM (LEVETIRACETAM)
1GM
Marketing Status: Discontinued

Active Ingredient: LEVETIRACETAM
Proprietary Name: SPRITAM
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 1GM
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207958
Product Number: 004
Approval Date: Jul 31, 2015
Applicant Holder Full Name: APRECIA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information