Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040866

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PRIMIDONE (PRIMIDONE)
50MG
Marketing Status: Prescription

Active Ingredient: PRIMIDONE
Proprietary Name: PRIMIDONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040866
Product Number: 001
Approval Date: Apr 23, 2008
Applicant Holder Full Name: AMNEAL PHARMACEUTICAL
Marketing Status:  Prescription
Patent and Exclusivity Information

PRIMIDONE (PRIMIDONE)
250MG
Marketing Status: Prescription

Active Ingredient: PRIMIDONE
Proprietary Name: PRIMIDONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040866
Product Number: 002
Approval Date: Apr 23, 2008
Applicant Holder Full Name: AMNEAL PHARMACEUTICAL
Marketing Status:  Prescription
Patent and Exclusivity Information