FDA
approval
· 2023-09-27
FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Original Application (Sun Pharmaceutical Industries, Inc.)
Summary
FDA approved Sun Pharmaceutical's original ANDA for a generic mixture of dextroamphetamine and amphetamine salts (dextroamphetamine saccharate, amphetamine aspa…
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Snippet
ORIG AP for DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE)