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HomeDrugsU.S. FDA Active Pharmaceutical Ingredients (API)API Examples › U.S. FDA Regulations: Isosorbide Mononitrate

U.S. FDA Requirements: Isosorbide Mononitrate

Pharmaceutical / Drug Definition : Promotes peripheral vasodilation and reduces preload and afterload, decreasing myocardial oxygen consumption and increasing cardiac output. Also dilates coronary arteries, increasing blood flow and improving collateral circulation.

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  • FDA Detentions Isosorbide Mononitrate (Isosorbide Mononitrate Entry Refusal)
  • General U.S. Food and Drug Administration Guidelines for:
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       - Processors Isosorbide Mononitrate
       - Repackers Isosorbide Mononitrate
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       - Importers Isosorbide Mononitrate
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U.S. FDA Regulations:

U.S. FDA Regulation: 21 C.F.R. Part 207


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