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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214918

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BRIVARACETAM (BRIVARACETAM)
10MG
Marketing Status: Discontinued
Active Ingredient: BRIVARACETAM
Proprietary Name: BRIVARACETAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214918
Product Number: 001
Approval Date: Dec 20, 2022
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
BRIVARACETAM (BRIVARACETAM)
25MG
Marketing Status: Discontinued
Active Ingredient: BRIVARACETAM
Proprietary Name: BRIVARACETAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214918
Product Number: 002
Approval Date: Dec 20, 2022
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
BRIVARACETAM (BRIVARACETAM)
50MG
Marketing Status: Discontinued
Active Ingredient: BRIVARACETAM
Proprietary Name: BRIVARACETAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214918
Product Number: 003
Approval Date: Dec 20, 2022
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
BRIVARACETAM (BRIVARACETAM)
75MG
Marketing Status: Discontinued
Active Ingredient: BRIVARACETAM
Proprietary Name: BRIVARACETAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214918
Product Number: 004
Approval Date: Dec 20, 2022
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
BRIVARACETAM (BRIVARACETAM)
100MG
Marketing Status: Discontinued
Active Ingredient: BRIVARACETAM
Proprietary Name: BRIVARACETAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214918
Product Number: 005
Approval Date: Dec 20, 2022
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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