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FDA approval · 2025-10-07

FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)

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Summary

FDA approved a supplemental ANDA for methylphenidate hydrochloride by SpecGx LLC. The action formalizes a change under the generic drug approval process.

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Diseases / indications

Drugs mentioned

  • METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)

Snippet

SUPPL AP for METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)