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

U.S. FDA Requirements: Dutasteride

Pharmaceutical / Drug Definition : Inhibits 5-alpha-reductase, an intracellular enzyme present in liver, skin, and prostate that's required for conversion of testosterone to 5-alpha-dihydrotestosterone (DHT). DHT appears to be the principal androgen responsible for stimulating prostatic growth.

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

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


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