PLAQUENIL

FDA-2026-P-4374 · 6 docket documents

Appco Pharma LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an ANDA for Hydroxychloroquine Sulfate Tablets USP 50 mg, a new strength differing from the reference listed drug PLAQUENIL Hydroxychloroquine Sulf

FDA-2025-P-1982 · 3 docket documents

America's Frontline Doctors, represented by Dr. Simone Gold, filed this citizen petition on June 26, 2025, requesting that the FDA initiate rulemaking to switch hydroxychloroquine sulfate (Plaquenil and equivalent products) from prescription-only to over-the-counter status pursuant to 21 U.S.C. § 35

FDA-2020-P-2066 · 4 docket documents

The America's Frontline Doctors and the Association of American Physicians and Surgeons filed this citizen petition on October 12, 2020, requesting that the FDA switch hydroxychloroquine sulfate and Plaquenil from prescription to over-the-counter status pursuant to 21 U.S.C. § 353(b)(3) and 21 C.F.R

FDA-2013-P-0170 · 3 docket documents

Clinipace Worldwide filed a suitability petition under Section 505(j)(2)(C) requesting that the FDA declare new strengths of hydroxychloroquine sulfate tablets (100, 300, and 400 mg) suitable for submission of an abbreviated new drug application (ANDA), with Sanofi-Aventis's Plaquenil 200 mg (NDA 09