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FDA approval · 2025-09-23

FDA Approved: METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE — Supplemental Application (KVK-Tech, Inc.)

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Summary

The FDA-approved supplemental application approves a generic extended-release methylphenidate hydrochloride product from KVK-Tech, Inc. for ADHD and narcolepsy.

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Diseases / indications

Drugs mentioned

  • METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE)

Snippet

SUPPL AP for METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE (METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE)