Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 218549

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ZUNVEYL (BENZGALANTAMINE GLUCONATE)
EQ 5MG BASE
Marketing Status: Prescription

Active Ingredient: BENZGALANTAMINE GLUCONATE
Proprietary Name: ZUNVEYL
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N218549
Product Number: 001
Approval Date: Jul 26, 2024
Applicant Holder Full Name: ALPHA COGNITION INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZUNVEYL (BENZGALANTAMINE GLUCONATE)
EQ 10MG BASE
Marketing Status: Prescription

Active Ingredient: BENZGALANTAMINE GLUCONATE
Proprietary Name: ZUNVEYL
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N218549
Product Number: 002
Approval Date: Jul 26, 2024
Applicant Holder Full Name: ALPHA COGNITION INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZUNVEYL (BENZGALANTAMINE GLUCONATE)
EQ 15MG BASE
Marketing Status: Prescription

Active Ingredient: BENZGALANTAMINE GLUCONATE
Proprietary Name: ZUNVEYL
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 15MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N218549
Product Number: 003
Approval Date: Jul 26, 2024
Applicant Holder Full Name: ALPHA COGNITION INC
Marketing Status:  Prescription
Patent and Exclusivity Information