FDA Approved: FOCALIN XR — Supplemental Application (Sandoz Inc)

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Summary

FDA approved a supplemental application for FOCALIN XR (dexmethylphenidate hydrochloride) by Sandoz Inc. The approval updates the existing NDA for the product.

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Diseases / indications

• Attention Deficit Hyperactivity Disorder

Drugs mentioned

• FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE)

Snippet

SUPPL AP for FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE)