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FDA approval · 2019-12-11

FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Original Application (Elite Laboratories, Inc.)

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Summary

The FDA approved Elite Laboratories' generic mixed amphetamine salts product under an original ANDA. The product contains four salt forms of amphetamine: dextro…

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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

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