FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)

View source ↗

Summary

FDA approved a supplemental NDA for a four-salt amphetamine product (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate,…

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, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE)