Requests that the FDA declare that an ANDA may be submitted for, Hydroxychloroquine Sulfate Tablets USP, 50 mg, a strength that differs from the currently approved RLD, PLAQUENIL (Hydroxychloroquine Sulfate) tablets from ADVANZ PHARMA (US), which FDA approved in 200 mg strengths prior to Jan 1, 1982 under NDA #009768 | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-4374

Requests that the FDA declare that an ANDA may be submitted for, Hydroxychloroquine Sulfate Tablets USP, 50 mg, a strength that differs from the currently approved RLD, PLAQUENIL (Hydroxychloroquine Sulfate) tablets from ADVANZ PHARMA (US), which FDA approved in 200 mg strengths prior to Jan 1, 1982 under NDA #009768

Documents

Comments

Description

Open

Key Dates

Comment Period OpensApr 21, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	May 6, 2026	--

Keywords

CDER

Suitability Petition

Appco Pharma LLC

Requests that the FDA

declare that an ANDA may be submitted for,

Hydroxychloroquine Sulfate Tablets USP, 50 mg,

a strength that differs from the currently

approved RLD, PLAQUENIL

Data from Regulations.gov