Hypogonadism

• FDA approval · 2009-01-06
  FDA Approved: TESTOSTERONE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for TESTOSTERONE from Strides Pharma Science Limited. The approval relates to testosterone replaceme…

• FDA approval · 2008-06-10
  FDA Approved: NOVAREL — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for NOVAREL (gonadotropin, chorionic) filed by Ferring Pharmaceuticals.

• FDA approval · 2007-12-27
  FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)

  FDA approved a supplemental application for ANDROGEL (testosterone) filed by ASCEND Therapeutics U.S., LLC.

• FDA approval · 2007-12-13
  FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)

  FDA approved a supplemental application for AndroGel (testosterone) from ASCEND Therapeutics U.S., LLC.

• FDA approval · 2007-10-11
  FDA Approved: DELESTROGEN — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Delestrogen (estradiol valerate) from Par Health USA, LLC, resulting in updated labeling for…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2007-05-23
  FDA Approved: TESTOSTERONE — Original Application (Strides Pharma Science Limited)

  The FDA approved Strides Pharma Science Limited's original ANDA for a generic testosterone product, establishing a generic option for testos…

• FDA approval · 2006-12-15
  FDA Approved: ELESTRIN — Original Application (Viatris Specialty LLC)

  FDA approved ELESTRIN (estradiol) via an original NDA; indicates estrogen replacement therapy for menopausal symptoms and related indication…