APPLICATION
NDA218549
TYPE
NDA
ORIGINAL APPROVAL
2024-07-26
LATEST ACTION
2024-07-26
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
ZUNVEYL · ReferencePrescription
BENZGALANTAMINE GLUCONATE EQ 10MG BASE · TABLET, DELAYED RELEASE · ORAL
ZUNVEYL · ReferencePrescription
BENZGALANTAMINE GLUCONATE EQ 15MG BASE · TABLET, DELAYED RELEASE · ORAL
ZUNVEYL · ReferencePrescription
BENZGALANTAMINE GLUCONATE EQ 5MG BASE · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-07-26Type 2 - New Active Ingredient and Type 3 - New Dosage Form · Original · standard — Review ↗AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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