Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205836

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BRIVIACT (BRIVARACETAM)
10MG Marketing Status: Prescription

Active Ingredient: BRIVARACETAM
Proprietary Name: BRIVIACT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205836
Product Number: 001
Approval Date: May 12, 2016
Applicant Holder Full Name: UCB INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BRIVIACT (BRIVARACETAM)
25MG Marketing Status: Prescription

Active Ingredient: BRIVARACETAM
Proprietary Name: BRIVIACT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205836
Product Number: 002
Approval Date: May 12, 2016
Applicant Holder Full Name: UCB INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BRIVIACT (BRIVARACETAM)
50MG Marketing Status: Prescription

Active Ingredient: BRIVARACETAM
Proprietary Name: BRIVIACT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205836
Product Number: 003
Approval Date: May 12, 2016
Applicant Holder Full Name: UCB INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BRIVIACT (BRIVARACETAM)
75MG Marketing Status: Prescription

Active Ingredient: BRIVARACETAM
Proprietary Name: BRIVIACT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205836
Product Number: 004
Approval Date: May 12, 2016
Applicant Holder Full Name: UCB INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BRIVIACT (BRIVARACETAM)
100MG Marketing Status: Prescription

Active Ingredient: BRIVARACETAM
Proprietary Name: BRIVIACT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205836
Product Number: 005
Approval Date: May 12, 2016
Applicant Holder Full Name: UCB INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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