Benign Prostatic Hyperplasia

• FDA approval · 2013-07-01
  FDA Approved: FINASTERIDE — Original Application (Dr Reddys Laboratories Inc)

  The FDA approved a generic FINASTERIDE product from Dr Reddys Laboratories Inc under an original ANDA.

• FDA approval · 2013-07-01
  FDA Approved: FINASTERIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical Industries' generic finasteride under an original application (ANDA 090508), with indications including beni…

• FDA approval · 2013-05-30
  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 · 2013-04-30
  FDA Approved: AVODART — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for Avodart (dutasteride) submitted by Waylis Therapeutics LLC.

• FDA approval · 2013-04-30
  FDA Approved: TAMSULOSIN HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic version of tamsulosin hydrochloride from Aurobindo Pharma Limited under an original ANDA. The product is used to trea…

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• FDA approval · 2013-04-26
  FDA Approved: FINASTERIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for finasteride submitted by Accord Healthcare, Inc.

• FDA approval · 2013-04-25
  FDA Approved: JALYN — Supplemental Application (Waylis Therapeutics)

  The FDA approved a supplemental application for Jalyn (dutasteride and tamsulosin hydrochloride) from Waylis Therapeutics.

• FDA approval · 2013-04-25
  FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for finasteride from Teva Pharmaceuticals USA, Inc. The approval updates the labeling for the generi…

• FDA approval · 2013-02-26
  FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Finasteride from Aurobindo Pharma Limited, confirming approval of a generic version of finas…

• FDA approval · 2013-02-22
  FDA Approved: FINASTERIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' supplemental ANDA for finasteride, a routine supplemental approval for a generic product.

• FDA approval · 2013-01-16
  FDA Approved: PROSCAR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for PROSCAR (finasteride) submitted by Organon LLC.

• FDA approval · 2012-09-28
  FDA Approved: FINASTERIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for finasteride submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2012-09-28
  FDA Approved: FINASTERIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for finasteride from Dr. Reddy's Laboratories Limited.

• FDA approval · 2012-09-27
  FDA Approved: FINASTERIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare, Inc.'s supplemental application for finasteride under ANDA 090121.

• FDA approval · 2012-08-30
  FDA Approved: ALFUZOSIN HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's Alfuzosin hydrochloride as a generic version of alfuzosin hydrochloride for the treatment of benign …

• FDA approval · 2012-06-27
  FDA Approved: JALYN — Supplemental Application (Waylis Therapeutics)

  FDA approved a supplemental application for JALYN, the combination product of dutasteride and tamsulosin hydrochloride. The submission was b…

• FDA approval · 2012-06-07
  FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for finasteride submitted by Teva Pharmaceuticals USA, Inc. The approval updates an existing fin…

• FDA approval · 2012-05-29
  FDA Approved: FINASTERIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved Dr. Reddy's Laboratories Limited's supplemental application for Finasteride, a generic product.

• FDA approval · 2012-05-23
  FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves the supplemental application for Finasteride from Aurobindo Pharma Limited, granting a generic Finasteride product under the AN…

• FDA approval · 2012-04-11
  FDA Approved: PROSCAR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for PROSCAR (finasteride) from Organon LLC. The action updates the regulatory approval for this …

• FDA approval · 2012-01-17
  FDA Approved: ALFUZOSIN HYDROCHLORIDE EXTENDED RELEASE — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s alfuzosin hydrochloride extended-release as an Original Application, providing a generic option for treati…

• FDA approval · 2011-10-31
  FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for tamsulosin hydrochloride submitted by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2011-10-27
  FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Tamsulosin Hydrochloride from Sandoz Inc, authorizing its generic product for the treatment of b…

• FDA approval · 2011-10-17
  FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (EXELAN PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for tamsulosin hydrochloride from Exelan Pharmaceuticals, indicating approval of a generic product.

• FDA approval · 2011-09-27
  FDA Approved: FINASTERIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for finasteride submitted by Dr. Reddy's Laboratories Limited.