Vasomotor Symptoms of Menopause

• FDA approval · 2025-04-22
  FDA Approved: PREMPRO — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application for Prempro (conjugated estrogens and medroxyprogesterone acetate) submitted by Wyeth/Pfizer to …

• FDA approval · 2024-02-15
  FDA Approved: ELESTRIN — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for ELESTRIN (estradiol) from Viatris Specialty LLC. The approval updates the labeling to incorporat…

• FDA approval · 2021-10-07
  FDA Approved: CLIMARA PRO — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Climara Pro (estradiol and levonorgestrel) submitted by Bayer, potentially updating labeling…

• FDA approval · 2019-02-05
  FDA Approved: DOTTI — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal's original application for DOTTI, a generic estradiol product, expanding availability of estrogen replacement therap…

• FDA approval · 2016-06-10
  FDA Approved: PAROXETINE — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's original ANDA for paroxetine (paroxetine hydrochloride), establishing a generic version of the antidepr…

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• FDA approval · 2008-03-03
  FDA Approved: PREMARIN — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Premarin (conjugated estrogens) from Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.