Premenstrual Dysphoric Disorder

• FDA label_change · 2024-06-12
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for PAROXETINE HYDROCHLORIDE submitted by Zydus Lifesciences Limited, resulting in changes to the pr…

• FDA label_change · 2023-08-18
  FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)

  FDA approved a supplemental application for Fluoxetine to update the labeling. The applicant is Chartwell Governmental & Specialty RX, LLC.

• FDA label_change · 2022-08-30
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for a sertraline hydrochloride generic from Quallent Pharmaceuticals Health LLC, updating the labeli…

• FDA label_change · 2021-09-21
  FDA Approved: FLUOXETINE — Supplemental Application (ScieGen Pharmaceuticals, Inc)

  FDA approved a supplemental application for fluoxetine by ScieGen Pharmaceuticals to update the labeling for this generic antidepressant.

• FDA label_change · 2021-09-20
  FDA Approved: ZOLOFT — Supplemental Application (ROERIG)

  FDA approved a supplemental application for Zoloft (sertraline hydrochloride) submitted by Roerig to update the product labeling.

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• FDA label_change · 2016-12-28
  FDA Approved: FLUOXETINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for fluoxetine from Dr. Reddy's Laboratories Limited, indicating a labeling-related update to the ge…

• FDA label_change · 2016-01-10
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for fluoxetine from Teva Pharmaceuticals USA, Inc. to update the product labeling.

• FDA label_change · 2013-02-01
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA supplemental approval for sertraline hydrochloride from Mylan to update labeling.

• FDA label_change · 2010-09-20
  FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for fluoxetine hydrochloride by PAI Holdings to modify the product labeling.

• FDA label_change · 2009-03-30
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Fluoxetine from Teva Pharmaceuticals USA, Inc., updating the labeling of the approved product.

• FDA label_change · 2006-09-20
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

  FDA approved a supplemental application for Prozac (fluoxetine hydrochloride) submitted by Dista Products Company, approving changes to the …