Approvals/FDA/dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

Approved

HUMAN PRESCRIPTION DRUG LABEL

2da8f9c9706a865b

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

Granules Pharmaceuticals Inc.🇺🇸 United States

FDA Page

Effective Date: May 13, 2026
Approval ID: 8c672e06-0778-4a7d-b398-5bcbf2a73f12
Products: 6 registered
Version: 6

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE and AMPHETAMINE SULFATE extended-release capsules These highlights do not include all the information needed to use DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE and AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES. 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 (Mixed Salts of a Single-Entity Amphetamine Product), for oral use, CII Initial U.S. Approval: 2001

Quick Stats

Total Products6

Labelers2

Label Sections40

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.