Benign Prostatic Hyperplasia

• FDA label_change · 2026-07-29
  FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (EXELAN PHARMACEUTICALS, INC.)

  FDA supplemental application for tamsulosin hydrochloride submitted by Exelan Pharmaceuticals; indicates a label change request or updates t…

• FDA label_change · 2024-08-22
  FDA Approved: FINASTERIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approves a supplemental application for finasteride from Accord Healthcare, Inc., resulting in labeling changes.

• FDA label_change · 2024-06-13
  FDA Approved: DOXAZOSIN — Supplemental Application (Upsher-Smith laboratories, LLC)

  FDA approved a supplemental application for doxazosin (doxazosin mesylate) from Upsher-Smith Laboratories, LLC. The action updates the produ…

• FDA label_change · 2021-07-16
  FDA Approved: SILODOSIN — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Silodosin submitted by Macleods Pharmaceuticals Limited. The action updates the labeling for Sil…

• FDA label_change · 2021-04-13
  FDA Approved: PROSCAR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for PROSCAR (finasteride) from Organon LLC. The approval entails changes to the product's labeli…

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• FDA label_change · 2020-01-30
  FDA Approved: AVODART — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for AVODART (dutasteride) filed by Waylis Therapeutics LLC, resulting in changes to the product labe…

• FDA label_change · 2017-02-21
  FDA Approved: DOXAZOSIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for doxazosin mesylate from Aurobindo Pharma Limited, resulting in a labeling update for the product…

• FDA label_change · 2015-06-08
  FDA Approved: CARDURA XL — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for CARDURA XL (doxazosin mesylate) by Viatris Specialty LLC, typically resulting in labeling change…

• FDA label_change · 2014-12-15
  FDA Approved: FINASTERIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Finasteride by Accord Healthcare, Inc., updating the drug's labeling. The supplement likely incl…

• FDA label_change · 2013-04-26
  FDA Approved: DOXAZOSIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for DOXAZOSIN (doxazosin mesylate) by Teva Pharmaceuticals USA, Inc., indicating an approved modific…

• FDA label_change · 2012-12-29
  FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for finasteride submitted by Teva Pharmaceuticals USA, Inc.

• FDA label_change · 2009-05-20
  FDA Approved: UROXATRAL — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approved a supplemental application for UROXATRAL (alfuzosin HCl) submitted by Advanz Pharma (US) Corp.