Benign Prostatic Hyperplasia

• FDA approval · 2023-07-25
  FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Amneal Pharmaceuticals of New York LLC's supplemental application for tamsulosin hydrochloride (generic), confirming approval o…

• FDA approval · 2023-06-07
  FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for tamsulosin hydrochloride submitted by Macleods Pharmaceuticals Limited.

• FDA approval · 2023-04-26
  FDA Approved: DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for Dutasteride and Tamsulosin Hydrochloride from Endo USA, Inc., approving the combination prod…

• FDA approval · 2023-04-26
  FDA Approved: DUTASTERIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for dutasteride from Aurobindo Pharma Limited under ANDA 202660.

• FDA approval · 2023-04-24
  FDA Approved: TADALAFIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for tadalafil filed by Camber Pharmaceuticals, Inc. This action grants an updated approval related t…

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• FDA approval · 2023-01-27
  FDA Approved: TADALAFIL — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for tadalafil filed by Solco Healthcare US, LLC.

• FDA approval · 2023-01-23
  FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for finasteride from Aurobindo Pharma Limited, granting approval for a generic finasteride product u…

• FDA approval · 2023-01-20
  FDA Approved: FINASTERIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare's supplemental application for Finasteride, granting a supplemental approval under the ANDA for this product.

• FDA approval · 2023-01-17
  FDA Approved: FINASTERIDE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for finasteride submitted by Ascend Laboratories, LLC.

• FDA approval · 2022-12-16
  FDA Approved: TADALAFIL — Supplemental Application (AvKARE)

  FDA supplemental approval for tadalafil from AvKARE (ANDA210608).

• FDA approval · 2022-10-12
  FDA Approved: ALYQ — Original Application (Teva Pharmaceuticals, Inc.)

  The FDA approved ALYQ as Teva's generic tadalafil in an original ANDA approval. The approval covers the same indications as tadalafil, inclu…

• FDA approval · 2022-09-23
  FDA Approved: ALFUZOSIN HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for Alfuzosin hydrochloride from Apotex Corp., approving changes related to this generic drug's …

• FDA approval · 2022-09-15
  FDA Approved: ALFUZOSIN HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Alfuzosin hydrochloride from Aurobindo Pharma Limited.

• FDA approval · 2022-08-11
  FDA Approved: TADALAFIL — Original Application (Solco Healthcare US, LLC)

  FDA approved an original ANDA for tadalafil tablets (generic tadalafil) by Solco Healthcare US, LLC. The product is approved for erectile dy…

• FDA approval · 2022-06-17
  FDA Approved: TADLIQ — Original Application (CMP Pharma, Inc.)

  FDA approved CMP Pharma's TadliQ (tadalafil) under Original Application NDA214522, approving its use for erectile dysfunction and benign pro…

• FDA approval · 2022-06-07
  FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2022-05-27
  FDA Approved: TADALAFIL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Tadalafil submitted by Aurobindo Pharma Limited. This action adds regulatory approval for th…

• FDA approval · 2022-05-24
  FDA Approved: SILODOSIN — Supplemental Application (Novadoz Pharmaceuticals LLC)

  FDA approved a supplemental application for silodosin. The applicant is Novadoz Pharmaceuticals LLC.

• FDA approval · 2022-05-18
  FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Finasteride submitted by Aurobindo Pharma Limited.

• FDA approval · 2022-05-18
  FDA Approved: TADALAFIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for tadalafil from Quallent Pharmaceuticals Health LLC. This action concerns the approval of a g…

• FDA approval · 2022-05-05
  FDA Approved: FINASTERIDE — Supplemental Application (Dr Reddys Laboratories Inc)

  FDA approved a supplemental application for finasteride from Dr Reddys Laboratories Inc., authorizing a generic Finasteride product.

• FDA approval · 2022-05-04
  FDA Approved: TAMSULOSIN HYDROCHLORIDE — Original Application (XLCare Pharmaceuticals, Inc)

  FDA approved an original application for tamsulosin hydrochloride from XLCare Pharmaceuticals, Inc., authorizing a generic version of tamsul…

• FDA approval · 2022-03-15
  FDA Approved: DOXAZOSIN — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for doxazosin (generic) by Rising Pharma Holdings, Inc., expanding access to this alpha-1 blocker for …

• FDA approval · 2022-03-11
  FDA Approved: FINASTERIDE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for finasteride from Ascend Laboratories, LLC, granting approval of a generic finasteride product un…

• FDA approval · 2022-03-11
  FDA Approved: FINASTERIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Camber Pharmaceuticals to market a generic finasteride product, expanding access to the referenc…