Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216185

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MOTPOLY XR (LACOSAMIDE)
100MG
Marketing Status: Prescription

Active Ingredient: LACOSAMIDE
Proprietary Name: MOTPOLY XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216185
Product Number: 001
Approval Date: May 4, 2023
Applicant Holder Full Name: AUCTA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MOTPOLY XR (LACOSAMIDE)
150MG
Marketing Status: Prescription

Active Ingredient: LACOSAMIDE
Proprietary Name: MOTPOLY XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216185
Product Number: 002
Approval Date: May 4, 2023
Applicant Holder Full Name: AUCTA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MOTPOLY XR (LACOSAMIDE)
200MG
Marketing Status: Prescription

Active Ingredient: LACOSAMIDE
Proprietary Name: MOTPOLY XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216185
Product Number: 003
Approval Date: May 4, 2023
Applicant Holder Full Name: AUCTA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information