Erectile Dysfunction

• 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: TADALAFIL — Original Application (Umedica Laboratories USA Inc.)

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

• FDA approval · 2020-08-25
  FDA Approved: SILDENAFIL CITRATE — Original Application (Northstar Rx LLC)

  The FDA approved sildenafil citrate from Northstar Rx LLC through an Original Application (ANDA 209302), making it a generic option for trea…

• FDA approval · 2020-08-04
  FDA Approved: VARDENAFIL HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original ANDA for vardenafil hydrochloride, a generic version of erectile dysfunction medicat…

• FDA approval · 2020-07-15
  FDA Approved: SILDENAFIL — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's supplemental application for sildenafil (generic sildenafil), authorizing the continued com…

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• FDA approval · 2020-06-12
  FDA Approved: SILDENAFIL — Original Application (Reyoung Corporation)

  FDA approved the original ANDA for sildenafil tablets from Reyoung Corporation for treating erectile dysfunction.

• FDA approval · 2020-06-11
  FDA Approved: SILDENAFIL — Original Application (HEC Pharm USA Inc.)

  The FDA approved HEC Pharm USA Inc.'s original application for sildenafil, confirming a generic version of the erectile dysfunction drug.

• FDA approval · 2020-05-29
  FDA Approved: SILDENAFIL — Original Application (Actavis Pharma, Inc.)

  FDA approved the original application for sildenafil as a generic product from Actavis Pharma, Inc. for erectile dysfunction.

• FDA approval · 2020-03-10
  FDA Approved: VARDENAFIL — Original Application (Macleods Pharmaceuticals Limited)

  FDA approves the original application for a generic Vardenafil by Macleods Pharmaceuticals Limited.

• FDA approval · 2020-03-02
  FDA Approved: SILDENAFIL — Original Application (Exelan Pharmaceuticals, Inc.)

  FDA approves an Original Application (ANDA) for sildenafil by Exelan Pharmaceuticals, enabling a generic version of the erectile dysfunction…

• FDA approval · 2020-02-21
  FDA Approved: SILDENAFIL — Supplemental Application (Aurobindo Pharma Limited)

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

• 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.

• FDA approval · 2020-01-15
  FDA Approved: SILDENAFIL — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for sildenafil from Amneal Pharmaceuticals of New York LLC to market a generic sildenafil produc…

• FDA approval · 2019-11-27
  FDA Approved: SILDENAFIL CITRATE — Original Application (Ascend Laboratories, LLC)

  FDA approved the original application for sildenafil citrate (generic) from Ascend Laboratories, LLC, establishing a generic version of the …

• FDA approval · 2019-11-27
  FDA Approved: SILDENAFIL — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved the original ANDA for sildenafil (SILDENAFIL) from Amneal Pharmaceuticals NY LLC, enabling a generic version of the erectil…

• FDA approval · 2019-11-27
  FDA Approved: SILDENAFIL — Original Application (Ajanta Pharma USA Inc.)

  FDA approves Ajanta Pharma USA Inc.'s original application for sildenafil (generic) for use in erectile dysfunction and pulmonary arterial h…

• FDA approval · 2019-10-22
  FDA Approved: VARDENAFIL HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approval of the original application for vardenafil hydrochloride from Macleods Pharmaceuticals Limited (ANDA 204632), making a generic …

• FDA approval · 2019-10-16
  FDA Approved: TADALAFIL — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Macleods Pharmaceuticals Limited's original ANDA for tadalafil, enabling a generic version of the medication.

• FDA approval · 2019-10-07
  FDA Approved: TADALAFIL — Original Application (Macleods Pharmaceuticals Limited)

  The FDA approved Macleods Pharmaceuticals Limited's original application for tadalafil (TADALAFIL) as a generic product.

• FDA approval · 2019-05-31
  FDA Approved: SILDENAFIL — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approves ANI Pharmaceuticals' sildenafil citrate as a generic drug under an original application.

• FDA approval · 2019-04-23
  FDA Approved: SILDENAFIL — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for sildenafil from Macleods Pharmaceuticals Limited, authorizing the marketing of a generic sildena…

• FDA approval · 2019-04-02
  FDA Approved: SILDENAFIL — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for sildenafil submitted by Torrent Pharmaceuticals Limited.

• FDA approval · 2019-03-29
  FDA Approved: TADALAFIL — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva's tadalafil generic (ANDA 205885) under Original Application. The product is indicated for erectile dysfunction and benign…

• FDA approval · 2019-03-26
  FDA Approved: TADALAFIL — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal's generic tadalafil tablets under an original ANDA, making a generic tadalafil available for erectile dysfunction and be…

• FDA approval · 2019-03-26
  FDA Approved: TADALAFIL — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved an Original Application (ANDA) for tadalafil submitted by Quallent Pharmaceuticals Health LLC.