Benign Prostatic Hyperplasia

• FDA approval · 2022-01-03
  FDA Approved: SILODOSIN — Original Application (Creekwood Pharmaceuticals LLC)

  FDA approves Creekwood Pharmaceuticals LLC's original application for silodosin. The drug is indicated for treatment of urinary symptoms due…

• FDA approval · 2021-11-22
  FDA Approved: SILODOSIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for silodosin from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2021-11-04
  FDA Approved: TADALAFIL — Original Application (Burel Pharmaceuticals, LLC)

  The FDA approved a generic tadalafil product under an original ANDA for Burel Pharmaceuticals, LLC.

• FDA approval · 2021-09-15
  FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for tamsulosin hydrochloride (Sandoz Inc.), authorizing the continued marketing of the generic w…

• FDA approval · 2021-08-25
  FDA Approved: PROSCAR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for PROSCAR (finasteride) by Organon LLC, resulting in updates to the product's labeling under t…

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• FDA approval · 2021-07-02
  FDA Approved: SILODOSIN — Supplemental Application (Ajanta Pharma USA Inc.)

  The FDA approved Ajanta Pharma USA Inc.'s supplemental application for silodosin, enabling regulatory clearance related to the generic produ…

• FDA approval · 2021-07-02
  FDA Approved: SILODOSIN — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic silodosin product from Aurobindo Pharma Limited. This action approves the generic …

• FDA approval · 2021-07-02
  FDA Approved: SILODOSIN — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved Alembic Pharmaceuticals Limited's supplemental application for silodosin, allowing a generic version to be marketed. The ap…

• FDA approval · 2021-07-02
  FDA Approved: SILODOSIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for silodosin under the ANDA206541, enabling the generic product's continued ma…

• FDA approval · 2021-06-23
  FDA Approved: DOXAZOSIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for doxazosin (doxazosin mesylate) from Mylan Pharmaceuticals. The drug is traditionally used to tre…

• FDA approval · 2021-06-22
  FDA Approved: CARDURA XL — Supplemental Application (Viatris Specialty LLC)

  FDA has approved a supplemental application for CARDURA XL (doxazosin mesylate) submitted by Viatris Specialty LLC.

• FDA approval · 2021-06-15
  FDA Approved: PROSCAR — Supplemental Application (Organon LLC)

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

• FDA approval · 2021-05-26
  FDA Approved: DUTASTERIDE — Supplemental Application (Epic Pharma, LLC)

  FDA approved Epic Pharma's supplemental application to bring a generic dutasteride product to market for the treatment of benign prostatic h…

• FDA approval · 2021-03-17
  FDA Approved: TADALAFIL — Supplemental Application (Cipla USA Inc.)

  The FDA approved a supplemental application for tadalafil from Cipla USA Inc. under ANDA210255, expanding the approved generic product for a…

• FDA approval · 2021-02-11
  FDA Approved: TADALAFIL — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for tadalafil from Macleods Pharmaceuticals Limited.

• FDA approval · 2021-01-07
  FDA Approved: TADALAFIL — Supplemental Application (HEC Pharm USA Inc.)

  The FDA approved a supplemental application for tadalafil from HEC Pharm USA Inc., indicating approval of an additional generic tadalafil pr…

• FDA approval · 2020-12-29
  FDA Approved: JALYN — Supplemental Application (Waylis Therapeutics)

  FDA approved a supplemental application for JALYN, a fixed-dose combination of dutasteride and tamsulosin hydrochloride, from Waylis Therape…

• FDA approval · 2020-10-27
  FDA Approved: N/A — Original Application (Bostal LLC)

  FDA approved an original application for tadalafil (generic) by Bostal LLC under ANDA 208824.

• FDA approval · 2020-10-23
  FDA Approved: DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for a generic combination product containing dutasteride and tamsulosin hydrochloride, manufactured …

• FDA approval · 2020-10-23
  FDA Approved: TADALAFIL — Original Application (Umedica Laboratories USA Inc.)

  FDA approved an original generic application for tadalafil (TADALAFIL) from Umedica Laboratories USA Inc.

• FDA approval · 2020-10-01
  FDA Approved: ALFUZOSIN HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Alfuzosin hydrochloride submitted by Sun Pharmaceutical Industries, Inc. The document does n…

• FDA approval · 2020-09-04
  FDA Approved: ALFUZOSIN HYDROCHLORIDE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approves a supplemental application for alfuzosin hydrochloride by Unichem Pharmaceuticals (USA), Inc., confirming its status as an appr…

• FDA approval · 2020-07-22
  FDA Approved: DUTASTERIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for a generic dutasteride product manufactured by Amneal Pharmaceuticals LLC.

• FDA approval · 2020-05-22
  FDA Approved: UROXATRAL — Supplemental Application (Advanz Pharma (US) Corp.)

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

• FDA approval · 2020-02-21
  FDA Approved: TADALAFIL — Supplemental Application (Dr.Reddys Laboratories Inc)

  FDA approved a supplemental application for tadalafil submitted by Dr.Reddys Laboratories Inc.