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HomeDrugsU.S. FDA Active Pharmaceutical Ingredients (API)API Examples › U.S. FDA Regulations: Irinotecan Hydrochloride

U.S. FDA Requirements: Irinotecan Hydrochloride

Pharmaceutical / Drug Definition : Inhibits topoisomerase 1 (an enzyme that allows DNA replication) by binding to it. This action prevents religation of DNA strand, which results in breakage of double-stranded DNA and cell death.

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  • FDA Registration Irinotecan Hydrochloride
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  • FDA Label Requirements and Exceptions Irinotecan Hydrochloride
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  • FDA Detentions Irinotecan Hydrochloride (Irinotecan Hydrochloride Entry Refusal)
  • General U.S. Food and Drug Administration Guidelines for:
       - Manufacturers Irinotecan Hydrochloride (Irinotecan Hydrochloride Suppliers)
       - Processors Irinotecan Hydrochloride
       - Repackers Irinotecan Hydrochloride
       - Relabelers Irinotecan Hydrochloride
       - Exporters Irinotecan Hydrochloride
       - Importers Irinotecan Hydrochloride
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U.S. FDA Regulations:

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


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