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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.

In the United States, Isosorbide Mononitrate is regulated by the U.S. Food and Drug Administration (FDA). FDA has specific requirements regarding the registration and listing of Isosorbide Mononitrate.

Registrar Corp assists Isosorbide Mononitrate companies with:

  • FDA Registration Isosorbide Mononitrate
  • FDA Listing Isosorbide Mononitrate
  • FDA Label Requirements and Exceptions Isosorbide Mononitrate
  • FDA Import Information Isosorbide Mononitrate
  • FDA Detentions Isosorbide Mononitrate (Isosorbide Mononitrate Entry Refusal)
  • General U.S. Food and Drug Administration Guidelines for:
       - Manufacturers Isosorbide Mononitrate (Isosorbide Mononitrate Suppliers)
       - Processors Isosorbide Mononitrate
       - Repackers Isosorbide Mononitrate
       - Relabelers Isosorbide Mononitrate
       - Exporters Isosorbide Mononitrate
       - Importers Isosorbide Mononitrate
For more information about Isosorbide Mononitrate, simply click below:

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U.S. FDA Regulations:

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

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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