Erectile Dysfunction

• FDA approval · 2015-02-03
  FDA Approved: SILDENAFIL CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for sildenafil citrate filed by Mylan Pharmaceuticals Inc., resulting in approval of the updated/exp…

• FDA approval · 2015-01-26
  FDA Approved: SILDENAFIL CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for sildenafil citrate (generic) filed by Mylan Pharmaceuticals Inc. The action pertains to a supple…

• FDA approval · 2015-01-12
  FDA Approved: CAVERJECT IMPULSE — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for CAVERJECT IMPULSE (alprostadil) submitted by Pharmacia & Upjohn Company LLC.

• FDA approval · 2014-08-15
  FDA Approved: SILDENAFIL — Supplemental Application (Torrent Pharmaceuticals Limited)

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

• FDA approval · 2014-06-12
  FDA Approved: CAVERJECT — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for CAVERJECT (alprostadil) by Pharmacia & Upjohn Company LLC. The snippet does not specify the …

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• FDA approval · 2014-06-11
  FDA Approved: CAVERJECT IMPULSE — Supplemental Application (Pharmacia & Upjohn Company LLC)

  FDA granted approval of a supplemental application for CAVERJECT IMPULSE (alprostadil) submitted by Pharmacia & Upjohn Company LLC.

• FDA approval · 2014-06-09
  FDA Approved: CAVERJECT — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved Pharmacia & Upjohn’s supplemental application for CAVERJECT (alprostadil). This constitutes an approved supplemental submis…

• FDA approval · 2014-03-28
  FDA Approved: CAVERJECT — Supplemental Application (Pharmacia & Upjohn Company LLC)

  FDA approved a supplemental application for CAVERJECT (alprostadil) from Pharmacia & Upjohn Company LLC.

• FDA approval · 2014-03-11
  FDA Approved: SILDENAFIL CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for sildenafil citrate from Mylan Pharmaceuticals, authorizing a generic sildenafil citrate product.…

• FDA approval · 2014-02-11
  FDA Approved: EDEX — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for EDEX (alprostadil) from Endo USA, Inc., authorizing changes to the product's labeling and approv…

• FDA approval · 2013-12-19
  FDA Approved: CAVERJECT IMPULSE — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for CAVERJECT IMPULSE (alprostadil) submitted by Pharmacia & Upjohn Company LLC.

• FDA approval · 2013-12-17
  FDA Approved: SILDENAFIL — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the Original Application for sildenafil citrate tablets from Macleods Pharmaceuticals Limited, providing a generic option for e…

• FDA approval · 2013-02-28
  FDA Approved: SILDENAFIL — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approves Amneal Pharmaceuticals of New York LLC's generic sildenafil under an original ANDA, for the same indications as the brand produ…

• FDA approval · 2012-12-10
  FDA Approved: SILDENAFIL — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for sildenafil submitted by Chartwell RX, LLC under ANDA202598.

• FDA approval · 2012-11-06
  FDA Approved: SILDENAFIL — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's original application for sildenafil tablets, granting a generic sildenafil product.

• FDA approval · 2012-11-06
  FDA Approved: SILDENAFIL — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's original ANDA for sildenafil, authorizing a generic version of sildenafil citrate.

• FDA approval · 2012-10-30
  FDA Approved: VARDENAFIL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves a supplemental application for Vardenafil hydrochloride (generic) submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2012-05-03
  FDA Approved: VARDENAFIL HYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's original application for vardenafil hydrochloride as a generic treatment for erectile dysfunction.

• FDA approval · 2010-02-01
  FDA Approved: CIALIS — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2008-08-07
  FDA Approved: CIALIS — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2008-08-06
  FDA Approved: SILDENAFIL CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for sildenafil citrate from Mylan Pharmaceuticals Inc., confirming approval of the generic produ…

• FDA approval · 2008-02-25
  FDA Approved: SILDENAFIL CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental NDA for sildenafil citrate filed by Mylan Pharmaceuticals Inc.

• FDA approval · 2007-10-18
  FDA Approved: SILDENAFIL CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for sildenafil citrate from Mylan Pharmaceuticals Inc.

• 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.