FDA Approval Documents

FDA Documents
[ All documents are in PDF format – Download Acrobat reader ]
Duagen (Dutasteride) Soft gel Capsules
Company: GlaxoSmithKline
Application No.: 21-319
Approval Date: 11/20/2001
  • Approval Letter(s)

  • Printed Labeling

  • Medical Review(s)
    Part 1
    Part 2

  • Chemistry Review(s)

  • Pharmacology Review(s)

  • Statistical Review(s)

  • Microbiology Review(s)

  • Clinical Pharmacology Biopharmaceutics Review(s)
    Part 1
    Part 2

  • Administrative Document(s)
    Part 1
    Part 2

  • Correspondence