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FDA approval · 2025-09-23

FDA Approved: COTEMPLA XR-ODT — Supplemental Application (Neos Therapeutics Brands, LLC)

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Summary

FDA approved a supplemental application for Cotempla XR-ODT (methylphenidate) from Neos Therapeutics Brands, LLC, expanding or updating the product labeling.

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Diseases / indications

Drugs mentioned

  • COTEMPLA XR-ODT (METHYLPHENIDATE)

Snippet

SUPPL AP for COTEMPLA XR-ODT (METHYLPHENIDATE)