Premenstrual Dysphoric Disorder

• FDA approval · 2026-03-26
  FDA Approved: PAROXETINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved Alembic Pharmaceuticals Inc.'s supplemental application for paroxetine (generic). This marks approval of a generic paroxeti…

• FDA approval · 2026-01-28
  FDA Approved: SERTRALINE HCL — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approves Amneal's generic sertraline hydrochloride tablet via an original ANDA. This decision enables generic competition for sertraline…

• FDA approval · 2026-01-20
  FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA-approved original application for sertraline hydrochloride generic (Dr. Reddy's Laboratories) for multiple indications.

• FDA approval · 2026-01-20
  FDA Approved: SERTRALINE HCL — Original Application (Biocon Pharma Inc.)

  FDA approved Biocon Pharma Inc.'s sertraline hydrochloride generic (SERTRALINE HCL) under ANDA218342, expanding access to the generic formul…

• FDA approval · 2026-01-15
  FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a fluoxetine generic product manufactured by Aurobindo Pharma Limited.

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• FDA approval · 2025-11-20
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for sertraline hydrochloride manufactured by Aurobindo Pharma Limited. This approval covers a generi…

• FDA approval · 2025-09-26
  FDA Approved: FLUOXETINE — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)

  FDA approves a supplemental application for fluoxetine hydrochloride from NIVAGEN Pharmaceuticals, enabling the marketing of a generic fluox…

• FDA approval · 2025-09-24
  FDA Approved: PAROXETINE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals Inc. Paroxetine Original Application for a generic paroxetine product.

• FDA approval · 2025-03-13
  FDA Approved: PAROXETINE — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for paroxetine hydrochloride (paroxetine) as a generic product under NorthStar Rx LLC's ANDA.

• FDA approval · 2025-02-28
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for paroxetine hydrochloride from Zydus Lifesciences Limited, adding regulatory approval for this ge…

• FDA approval · 2025-02-15
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (XLCare Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Sertraline Hydrochloride from XLCare Pharmaceuticals, Inc., authorizing the generic product.

• FDA approval · 2025-02-11
  FDA Approved: PAROXETINE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for paroxetine (Padagis US LLC), updating the labeling to reflect expanded indications for the antid…

• FDA approval · 2025-01-29
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride (generic sertraline), authorizing the generic prod…

• FDA approval · 2024-11-07
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Accord Healthcare's sertraline hydrochloride, a generic version of sertraline, maintaining the u…

• FDA approval · 2024-09-13
  FDA Approved: FLUOXETINE HCL — Original Application (Strides Pharma Science Limited)

  FDA approved a generic fluoxetine hydrochloride product from Strides Pharma Science Limited via an original ANDA. The approval confirms the …

• FDA approval · 2024-08-29
  FDA Approved: PAROXETINE — Supplemental Application (Modavar Pharmaceuticals LLC)

  The FDA approved a supplemental application for paroxetine from Modavar Pharmaceuticals LLC.

• FDA approval · 2024-08-29
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved the supplemental application for Fluoxetine Hydrochloride from Taro Pharmaceuticals U.S.A., Inc. (ANDA211477), enabling the mar…

• FDA approval · 2024-05-02
  FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for the generic fluoxetine from Aurobindo Pharma Limited (ANDA213265).

• FDA approval · 2024-04-05
  FDA Approved: FLUOXETINE — Original Application (Strides Pharma Science Limited)

  FDA approved an Original Application for a generic Fluoxetine from Strides Pharma Science Limited, enabling a generic version of fluoxetine …

• FDA approval · 2024-02-02
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for sertraline hydrochloride from Rising Pharma Holdings, Inc., resulting in approval of a gener…

• FDA approval · 2024-01-19
  FDA Approved: PAROXETINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Paroxetine by ANI Pharmaceuticals, Inc., indicating approval of a generic product under ANDA 215…

• FDA approval · 2024-01-09
  FDA Approved: FLUOXETINE — Supplemental Application (Vensun Pharmaceuticals, Inc.)

  FDA approved a supplemental application for fluoxetine hydrochloride from Vensun Pharmaceuticals, Inc., granting approval of a generic fluox…

• FDA approval · 2023-11-20
  FDA Approved: FLUOXETINE — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for fluoxetine submitted by Endo USA, Inc., resulting in regulatory changes to the product's sta…

• FDA approval · 2023-09-22
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)

  FDA approved a supplemental application for sertraline hydrochloride from Granules Pharmaceuticals Inc. The action confirms continued approv…

• FDA approval · 2023-09-19
  FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for fluoxetine submitted by Aurobindo Pharma Limited. This action updates the regulatory status …