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. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-6706

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.

Documents

Comments

Key Dates

Comment Period OpensJun 11, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Jul 1, 2026	--

Keywords

CDER

Appco Pharma LLC

Suitability Petition

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

Data from Regulations.gov