FDA
approval
· 2025-03-05
FDA Approved: MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR — Supplemental Application (SpecGx LLC)
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
Snippet
SUPPL AP for MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE)