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
🏛 Food and Drug Administration (FDA)FDA-2026-P-4374
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