Benign Prostatic Hyperplasia

• FDA approval · 2007-05-01
  FDA Approved: TERAZOSIN — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved a supplemental application for Terazosin hydrochloride from Jubilant Cadista Pharmaceuticals, resulting in labeling changes.

• FDA approval · 2007-03-29
  FDA Approved: UROXATRAL — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approved a supplemental application for UROXATRAL (alfuzosin HCl) from Advanz Pharma US Corp. The action confirms regulatory clearance r…

• FDA approval · 2007-02-28
  FDA Approved: FINASTERIDE — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approves Dr. Reddy's Laboratories' generic finasteride (Original Application) for indications including benign prostatic hyperplasia and…

• FDA approval · 2006-12-15
  FDA Approved: FINASTERIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a generic version of finasteride through an original application submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2006-12-15
  FDA Approved: DOXAZOSIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for doxazosin mesylate (DOXAZOSIN) submitted by Teva Pharmaceuticals USA, Inc.

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• FDA approval · 2006-11-16
  FDA Approved: UROXATRAL — Supplemental Application (Advanz Pharma (US) Corp.)

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

• FDA approval · 2006-10-23
  FDA Approved: CIALIS — Supplemental Application (Eli Lilly and Company)

  FDA approves a supplemental application for Cialis (tadalafil) submitted by Eli Lilly and Company.

• FDA approval · 2006-07-28
  FDA Approved: FINASTERIDE — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approves Dr. Reddy's Laboratories' generic finasteride as an original ANDA (ANDA 076436).

• FDA approval · 2006-06-07
  FDA Approved: DOXAZOSIN — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application from Apotex Corp. for doxazosin (generic), confirming regulatory clearance related to this generic p…