Approvals/FDA/Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

Approved

HUMAN PRESCRIPTION DRUG LABEL

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Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

ANI Pharmaceuticals, Inc.🇺🇸 United States

FDA Page

Effective Date: May 15, 2026
Approval ID: 6438480f-1147-42b6-826d-4e1e1f8ff007
Products: 6 registered
Version: 13

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES.DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE (mixed salts of a single-entity amphetamine product) extended-release capsules, for oral use, CIIInitial U.S. Approval: 2001

Quick Stats

Total Products6

Labelers2

Label Sections25

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.