Approvals/FDA/Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release

Approved

HUMAN PRESCRIPTION DRUG LABEL

7938c6045fefba8b

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release

Bryant Ranch Prepack🇺🇸 United States

FDA Page

Effective Date: Jan 12, 2024
Approval ID: 35baeeb9-5604-4e03-b049-8417a27d2089
Products: 1 registered
Version: 101

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 extended-release capsules, for oral use. CII Initial U.S. Approval: 2001

Quick Stats

Total Products1

Labelers2

Label Sections20

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.