| United States Regulations -> FDA (Food and Drug Administration) -> 21 CFR 210/11 |
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| United States Regulations -> FDA (Food and Drug Administration) -> 21 CFR 332.10 |
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| United States Regulations -> FDA (Food and Drug Administration) -> Drug Master File |
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| Europe Regulations -> No current Ph.Eur. monograph -> Technical File available |
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| United States Regulations -> USP (U.S. Pharmacopeia) -> Tested & Certified to Meet USP Monograph Requirements for Simethicone Emulsion USP |
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