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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212690

XYWAV (CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE)
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML
Marketing Status: Prescription
Active Ingredient: CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
Proprietary Name: XYWAV
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212690
Product Number: 001
Approval Date: Jul 21, 2020
Applicant Holder Full Name: JAZZ PHARMACEUTICALS IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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