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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214755

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LUMRYZ (SODIUM OXYBATE)
4.5GM/PACKET
Marketing Status: Prescription
Active Ingredient: SODIUM OXYBATE
Proprietary Name: LUMRYZ
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; ORAL
Strength: 4.5GM/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214755
Product Number: 001
Approval Date: May 1, 2023
Applicant Holder Full Name: AVADEL CNS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LUMRYZ (SODIUM OXYBATE)
6GM/PACKET
Marketing Status: Prescription
Active Ingredient: SODIUM OXYBATE
Proprietary Name: LUMRYZ
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; ORAL
Strength: 6GM/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214755
Product Number: 002
Approval Date: May 1, 2023
Applicant Holder Full Name: AVADEL CNS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LUMRYZ (SODIUM OXYBATE)
7.5GM/PACKET
Marketing Status: Prescription
Active Ingredient: SODIUM OXYBATE
Proprietary Name: LUMRYZ
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; ORAL
Strength: 7.5GM/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214755
Product Number: 003
Approval Date: May 1, 2023
Applicant Holder Full Name: AVADEL CNS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LUMRYZ (SODIUM OXYBATE)
9GM/PACKET
Marketing Status: Prescription
Active Ingredient: SODIUM OXYBATE
Proprietary Name: LUMRYZ
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; ORAL
Strength: 9GM/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214755
Product Number: 004
Approval Date: May 1, 2023
Applicant Holder Full Name: AVADEL CNS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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