Requests that the FDA declare that an ANDA may be submitted for, Acetazolamide Tablets, USP 500 mg a strength that differs from the currently approved RLD, DIAMOX (Acetazolamide) tablets from TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC, which FDA approved in 125 mg and 250 mg strengths prior to Jan 1, 1982 under NDA #008943
🏛 Food and Drug Administration (FDA)FDA-2026-P-4761
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