Menopause

• FDA approval · 2009-05-18
  FDA Approved: PREMPRO — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for PREMPRO (conjugated estrogens and medroxyprogesterone acetate) from Wyeth Pharmaceuticals (Pfize…

• FDA approval · 2008-01-25
  FDA Approved: ESTROGEL — Supplemental Application (ASCEND Therapeutics US, LLC)

  The FDA approved a supplemental application for ESTROGEL (estradiol) submitted by ASCEND Therapeutics US, 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…

• FDA approval · 2007-07-27
  FDA Approved: EVAMIST — Original Application (Padagis US LLC)

  The FDA approves Evamist (estradiol) from Padagis US LLC under NDA 022014 for the treatment of vasomotor symptoms associated with menopause.

• FDA approval · 2007-06-04
  FDA Approved: DIVIGEL — Original Application (Vertical Pharmaceuticals, LLC)

  FDA approved Divigel, an estradiol topical gel, under the Original Application from Vertical Pharmaceuticals, LLC.

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• FDA approval · 2007-02-14
  FDA Approved: FEMRING — Supplemental Application (Millicent US, Inc.)

  FDA approved a supplemental application for FEMRING (estradiol acetate) from Millicent US, Inc., updating/expanding the product's labeling p…

• 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…