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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021196

XYREM (SODIUM OXYBATE)
0.5GM/ML
Marketing Status: Prescription
Active Ingredient: SODIUM OXYBATE
Proprietary Name: XYREM
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 0.5GM/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021196
Product Number: 001
Approval Date: Jul 17, 2002
Applicant Holder Full Name: JAZZ PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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