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FDA approval · 2021-01-13

FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Original Application (Rhodes Pharmaceuticals L.P.)

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Summary

FDA approves Rhodes Pharmaceuticals' original ANDA for a four-salt generic amphetamine product indicated for attention-deficit/hyperactivity disorder and narcol…

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Diseases / indications

Drugs mentioned

  • Amphetamine aspartate monohydrate (Amphetamine aspartate monohydrate)
  • Amphetamine sulfate (amphetamine sulfate)
  • Dextroamphetamine Saccharate
  • Dextroamphetamine sulfate (dextroamphetamine sulfate)

Snippet

ORIG AP for DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE)