Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206709

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DIACOMIT (STIRIPENTOL)
250MG
Marketing Status: Prescription

Active Ingredient: STIRIPENTOL
Proprietary Name: DIACOMIT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 250MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N206709
Product Number: 001
Approval Date: Aug 20, 2018
Applicant Holder Full Name: BIOCODEX SA
Marketing Status:  Prescription
Patent and Exclusivity Information

DIACOMIT (STIRIPENTOL)
500MG
Marketing Status: Prescription

Active Ingredient: STIRIPENTOL
Proprietary Name: DIACOMIT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N206709
Product Number: 002
Approval Date: Aug 20, 2018
Applicant Holder Full Name: BIOCODEX SA
Marketing Status:  Prescription
Patent and Exclusivity Information