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

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Summary

FDA approved an original ANDA for a mixed-salts amphetamine product by SpecGx LLC, comprising multiple dextroamphetamine/amphetamine salts.

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Diseases / indications

• Attention Deficit Hyperactivity Disorder
• Narcolepsy

Drugs mentioned

• Mixed salts of a single-entity amphetamine product (Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate)

Snippet

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