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FDA approval · 2025-03-05

FDA Approved: MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR — Supplemental Application (SpecGx LLC)

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Summary

FDA approved a supplemental application for Mixed Salts of a Single Entity Amphetamine Product XR, a generic extended-release amphetamine product (SpecGx LLC).

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Diseases / indications

Drugs mentioned

  • MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR (DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE)

Snippet

SUPPL AP for MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE)