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FDA approval · 2023-10-20

FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII — Supplemental Application (Alvogen Inc.)

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Summary

FDA approves Alvogen Inc.'s supplemental application to market generic mixed amphetamine salts tablets (dextroamphetamine/amphetamines) in multiple strengths (5…

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Diseases / indications

Drugs mentioned

  • Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, CII (Mixed amphetamine salts (dextroamphetamine and amphetamine) tablets)

Snippet

SUPPL AP for DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS, 5 MG,CLL)