Hypoestrogenism

• FDA approval · 2024-10-23
  FDA Approved: ESTRADIOL — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' generic estradiol product under an original application.

• FDA approval · 2024-08-26
  FDA Approved: ESTRADIOL — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Estradiol by Zydus Pharmaceuticals USA Inc., associated with the generic product's approval upda…

• FDA approval · 2024-07-12
  FDA Approved: ESTRADIOL — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's Original Application for Estradiol transdermal, a generic estradiol product. The approval c…

• FDA approval · 2024-04-22
  FDA Approved: ESTRADIOL — Original Application (Solaris Pharma Corporation)

  FDA approves Solaris Pharma Corporation's Estradiol as an original application (generic) product for estrogen replacement therapy.

• FDA approval · 2023-11-20
  FDA Approved: LYLLANA — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for LYLLANA (estradiol) from Amneal Pharmaceuticals LLC (ANDA 211396).

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• FDA approval · 2023-11-14
  FDA Approved: ESTRADIOL — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved an Estradiol generic product from Padagis Israel Pharmaceuticals Ltd under an Original Application, enabling its use for estrog…

• FDA approval · 2023-08-24
  FDA Approved: ESTRADIOL — Original Application (NorthStar Rx LLC)

  FDA approved NorthStar Rx LLC's Estradiol as an original-application generic product (ANDA217610).

• FDA approval · 2023-04-28
  FDA Approved: ESTRADIOL VALERATE — Original Application (Xiromed, LLC)

  The FDA approved Xiromed, LLC's Estradiol Valerate as an original-application generic (ANDA 216656), authorizing its marketing for approved …

• FDA approval · 2018-08-27
  FDA Approved: ESTRADIOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Estradiol submitted by Mylan Pharmaceuticals Inc., granting regulatory approval for changes …

• 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 · 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 · 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 · 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…