FDA Approved: MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR — Original Application (SpecGx LLC)

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Summary

FDA approved the original ANDA for MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR, a generic extended-release amphetamine formulation from SpecGx LLC.

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Diseases / indications

• Attention Deficit Hyperactivity Disorder
• Narcolepsy

Drugs mentioned

• MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR (DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE)

Snippet

ORIG AP for MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE)