FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE EXTENDED-RELEASE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

View source ↗

Summary

FDA approved Sun Pharmaceutical's supplemental application for a generic mixed amphetamine salts extended-release product (dextroamphetamine and amphetamine sal…

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

• Attention Deficit Hyperactivity Disorder
• Narcolepsy

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, AMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE)