FDA Approved: SODIUM OXYBATE — Original Application (Amneal Pharmaceuticals LLC)

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Summary

FDA approved the original ANDA for sodium oxybate by Amneal Pharmaceuticals LLC, establishing a generic version of the drug. The approved indication corresponds…

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Diseases / indications

• Narcolepsy
• Narcolepsy with Cataplexy

Drugs mentioned

• Sodium Oxybate (Sodium Oxybate)

Snippet

ORIG AP for SODIUM OXYBATE (SODIUM OXYBATE)