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FDA approval · 2024-02-27

FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Granules Pharmaceuticals Inc.)

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Summary

FDA approved a supplemental application from Granules Pharmaceuticals Inc. for a generic product containing four amphetamine/dextroamphetamine salts (dextroamph…

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Diseases / indications

Drugs mentioned

  • Dextroamphetamine saccharate; amphetamine aspartate monohydrate; dextroamphetamine sulfate; amphetamine sulfate (dextroamphetamine saccharate; amphetamine aspartate monohydrate; dextroamphetamine sulfate; amphetamine sulfate)

Snippet

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