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Requests that the FDA declare that an ANDA may be submitted for, Modafinil Tablets, USP 50 mg and 150 mg, 2 strengths that differ from the currently approved RLD, PROVIGIL (Modafinil) tablets from NUVO PHARMACEUTICALS (IRELAND) DAC, which FDA approved in 100 mg and 200 mg strengths on Dec 24th, 1998 under NDA #020717.
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Attachment 1
Attachment 1
Nonrulemaking
Supporting & Related Material
FDA-2026-P-6706-0003
Pharmaceutical Policy
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Posted
Jun 11, 2026
Agency
Food and Drug Administration (FDA)
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