Menopause

• 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 · 2019-01-04
  FDA Approved: ESTRADIOL — Supplemental Application (PURACAP LABORATORIES, LLC)

  The FDA granted approval for a supplemental application for Estradiol submitted by Puracap Laboratories, LLC, approving changes to an Estrad…

• FDA approval · 2018-10-28
  FDA Approved: BIJUVA — Original Application (Mayne Pharma)

  The FDA approved BIJUVA, a fixed-dose combination of estradiol and progesterone from Mayne Pharma, for relief of moderate to severe vasomoto…

• FDA approval · 2018-08-17
  FDA Approved: DIVIGEL — Supplemental Application (Vertical Pharmaceuticals, LLC)

  FDA approved a supplemental application for Divigel (estradiol) submitted by Vertical Pharmaceuticals, LLC.

• FDA approval · 2017-11-07
  FDA Approved: CONJUGATED ESTROGENS — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Conjugated Estrogens (Estrogens, Conjugated) submitted by Prasco Laboratories.

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• FDA approval · 2017-11-01
  FDA Approved: DIVIGEL — Supplemental Application (Vertical Pharmaceuticals, LLC)

  The FDA approved a supplemental application for DIVIGEL (estradiol) from Vertical Pharmaceuticals, LLC. This action updates labeling and/or …

• FDA approval · 2017-07-21
  FDA Approved: ESTRADIOL — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc. for Estradiol as a new generic product under an Original Application (ANDA206388).

• FDA approval · 2017-02-10
  FDA Approved: ABIGALE LO — Original Application (Xiromed LLC)

  FDA approved ABIGALE LO, a generic combination of estradiol and norethindrone acetate, under an Original Application by Xiromed LLC. It is a…

• FDA approval · 2016-05-04
  FDA Approved: PREMPRO — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application for PREMPRO, a combination of conjugated estrogens and medroxyprogesterone acetate, from Wyeth P…

• FDA approval · 2016-02-25
  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 · 2015-08-31
  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 · 2015-06-11
  FDA Approved: ESTROGEL — Supplemental Application (ASCEND Therapeutics US, LLC)

  The FDA approved a supplemental application for ESTROGEL, an estradiol topical gel, submitted by ASCEND Therapeutics US, LLC.

• FDA approval · 2015-05-29
  FDA Approved: YUVAFEM — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal's YUVAFEM, a generic estradiol product, under an Original Application (ANDA205256).

• FDA approval · 2015-01-26
  FDA Approved: ANGELIQ — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved ANGELIQ—Supplemental Application for the Bayer HealthCare Pharmaceuticals Inc. product. The approval concerns the drospirenone …

• FDA approval · 2014-12-19
  FDA Approved: ESTRADIOL — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved an original application for a generic estradiol product from Mylan Pharmaceuticals.

• FDA approval · 2014-09-25
  FDA Approved: PREMARIN VAGINAL — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application for Premarin Vaginal (conjugated estrogens) from Wyeth Pharmaceuticals (Pfizer) to modify the pr…

• FDA approval · 2014-07-31
  FDA Approved: VIVELLE-DOT — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for VIVELLE-DOT (estradiol) from Sandoz Inc., updating the product labeling.

• FDA approval · 2014-04-11
  FDA Approved: CONJUGATED ESTROGENS — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for conjugated estrogens (Estrogens, Conjugated) filed by Prasco Laboratories, representing a regula…

• FDA approval · 2014-02-27
  FDA Approved: ELESTRIN — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for ELESTRIN (estradiol) submitted by Viatris Specialty LLC.

• FDA approval · 2013-09-19
  FDA Approved: COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) — Supplemental Application (Noven Therapeutics, LLC)

  The FDA approved a supplemental application for COMBIPATCH, a transdermal patch delivering estradiol and norethindrone acetate.

• FDA approval · 2012-04-11
  FDA Approved: PREMARIN — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Premarin (conjugated estrogens) filed by Wyeth Pharmaceuticals, a Pfizer subsidiary. The submiss…

• FDA approval · 2012-02-02
  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) submitted by Wyeth Pharmaceutical…

• FDA approval · 2011-10-26
  FDA Approved: EVAMIST — Supplemental Application (Padagis US LLC)

  The FDA approved a supplemental application for EVAMIST (estradiol) submitted by Padagis US LLC.

• FDA approval · 2010-01-19
  FDA Approved: ESTRADIOL VALERATE — Original Application (American Regent, Inc.)

  FDA approved Estradiol Valerate under an Original Application (ANDA 090920), granting a new generic product status to American Regent, Inc.

• FDA approval · 2009-12-30
  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) filed by Wyeth Pharmaceutical…