Polycystic Ovary Syndrome

• FDA approval · 2026-08-11
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Laurus Labs Limited)

  FDA supplemental application approval for Metformin Hydrochloride (generic) by Laurus Labs Limited.

• FDA approval · 2026-08-11
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (ACTAVIS ELIZABETH)

  Supplemental application approval for Metformin Hydrochloride by Actavis Elizabeth.

• FDA approval · 2026-02-24
  FDA Approved: CLOMID — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for CLOMID (clomiphene citrate) submitted by Cosette Pharmaceuticals, Inc.

• FDA approval · 2025-12-18
  FDA Approved: CLOMID — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for CLOMID (clomiphene citrate) from Cosette Pharmaceuticals, Inc., clearing a generic version under…

• FDA approval · 2025-10-17
  FDA Approved: CLOMIPHENE CITRATE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' generic clomiphene citrate for the treatment of infertility due to ovulatory dysfunction as an original ap…

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• FDA approval · 2025-10-03
  FDA Approved: CLOMIPHENE CITRATE — Original Application (Accord Healthcare Inc.)

  The FDA approved an original application for a generic clomiphene citrate product from Accord Healthcare Inc. (CLOMIPHENE CITRATE).

• FDA approval · 2021-05-17
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Laurus Labs Limited)

  FDA approved a supplemental application for Metformin Hydrochloride by Laurus Labs Limited under ANDA 209882; this action updates/expands th…

• FDA approval · 2019-08-27
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Metformin Hydrochloride from Amneal Pharmaceuticals of New York LLC, sanctioning changes to …

• FDA approval · 2019-08-27
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for metformin hydrochloride from Amneal Pharmaceuticals LLC, a generic formulation.

• FDA approval · 2019-02-22
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)

  The FDA approved Granules Pharmaceuticals Inc.'s supplemental application for METFORMIN HYDROCHLORIDE, indicating an approved modification t…

• FDA approval · 2019-01-02
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Precision Dose, Inc.)

  FDA approved a supplemental application for metformin hydrochloride from Precision Dose, Inc., under the existing NDA.

• FDA approval · 2017-10-31
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved an original application for METFORMIN HYDROCHLORIDE from Macleods Pharmaceuticals Limited, adding a generic metformin hydrochlo…

• FDA approval · 2012-07-20
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original ANDA for metformin hydrochloride, a generic form used to treat type 2 diabetes mellitus (an…

• FDA approval · 2010-11-19
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Metformin Hydrochloride (Sun Pharmaceutical Industries, Inc.), a generic metformin product.

• FDA approval · 2010-07-02
  FDA Approved: SPIRONOLACTONE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original application for generic spironolactone, establishing a bioequivalent product to the refer…

• FDA approval · 2008-01-03
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's metformin hydrochloride generic under an Original Application (ANDA). The approval makes a met…

• FDA approval · 2007-02-15
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for metformin hydrochloride from Amneal Pharmaceuticals of New York LLC, granting regulatory app…