Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211964

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QELBREE (VILOXAZINE HYDROCHLORIDE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: VILOXAZINE HYDROCHLORIDE
Proprietary Name: QELBREE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211964
Product Number: 001
Approval Date: Apr 2, 2021
Applicant Holder Full Name: SUPERNUS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

QELBREE (VILOXAZINE HYDROCHLORIDE)
EQ 150MG BASE
Marketing Status: Prescription

Active Ingredient: VILOXAZINE HYDROCHLORIDE
Proprietary Name: QELBREE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211964
Product Number: 002
Approval Date: Apr 2, 2021
Applicant Holder Full Name: SUPERNUS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

QELBREE (VILOXAZINE HYDROCHLORIDE)
EQ 200MG BASE
Marketing Status: Prescription

Active Ingredient: VILOXAZINE HYDROCHLORIDE
Proprietary Name: QELBREE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211964
Product Number: 003
Approval Date: Apr 2, 2021
Applicant Holder Full Name: SUPERNUS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information