Premenstrual Dysphoric Disorder

• FDA approval · 2011-03-11
  FDA Approved: YAZ — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Yaz (drospirenone and ethinyl estradiol) from Bayer HealthCare Pharmaceuticals, indicating a…

• FDA approval · 2011-03-04
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for paroxetine hydrochloride from Zydus Lifesciences Limited.

• FDA approval · 2011-01-30
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Paroxetine hydrochloride by Zydus Lifesciences Limited, indicating an update to the labeling or …

• FDA approval · 2010-12-10
  FDA Approved: PAROXETINE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for paroxetine hydrochloride (paroxetine) submitted by NorthStar Rx LLC. This action represents an a…

• 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.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2010-05-19
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for fluoxetine submitted by Teva Pharmaceuticals USA, Inc. (the snippet does not specify the exact c…

• FDA approval · 2010-03-25
  FDA Approved: PAROXETINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for paroxetine hydrochloride hemihydrate from Mylan Pharmaceuticals Inc., advancing the generic …

• FDA approval · 2010-03-25
  FDA Approved: PAROXETINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for paroxetine hydrochloride from Apotex Corp., granting approval for an additional generic product.

• FDA approval · 2010-03-22
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approved a generic version of fluoxetine hydrochloride (an SSRI) from Dr. Reddy's Laboratories Limited under an Original Application (AN…

• CLINICAL_TRIALS trial_result · 2010-03-02
  Clinical Trial Update: Altered Calcium and Vitamin D in PMDD or Severe PMS [NA]

  Clinical trial evaluating altered calcium and vitamin D in PMDD and severe PMS has completed.

• FDA approval · 2009-09-28
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for fluoxetine from Teva Pharmaceuticals USA, Inc., updating the approval status of the drug. Th…

• FDA approval · 2009-09-28
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)

  FDA approved the supplemental application for sertraline hydrochloride from Granules Pharmaceuticals Inc., confirming regulatory approval of…

• FDA approval · 2009-09-28
  FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)

  FDA approved a supplemental application for fluoxetine (generic) filed by Chartwell Governmental & Specialty RX, LLC. The approval confirms …

• FDA approval · 2009-08-31
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for sertraline hydrochloride from Quallent Pharmaceuticals Health LLC, enabling the generic prod…

• FDA approval · 2009-08-21
  FDA Approved: FLUOXETINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for generic fluoxetine from Dr. Reddy's Laboratories Limited.

• FDA approval · 2009-08-07
  FDA Approved: PAXIL — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application from Apotex Corp for Paxil (paroxetine hydrochloride).

• FDA approval · 2009-04-21
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)

  FDA approved a supplemental application for sertraline hydrochloride from Granules Pharmaceuticals Inc., indicating approval of a modificati…

• 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 approval · 2009-03-19
  FDA Approved: FLUOXETINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for Fluoxetine by Aurobindo Pharma Limited, enabling a generic Fluoxetine product. The approved indica…

• FDA approval · 2009-02-25
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for sertraline hydrochloride from Aurobindo Pharma Limited, a generic version of the antidepressant …

• FDA approval · 2009-01-30
  FDA Approved: ZOLOFT — Supplemental Application (ROERIG)

  FDA approved a supplemental application for Zoloft (sertraline hydrochloride) submitted by ROERIG.

• FDA approval · 2009-01-30
  FDA Approved: PAROXETINE HYDROCHLORIDE — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for PAROXETINE HYDROCHLORIDE from Apotex Corp.

• FDA approval · 2008-10-31
  FDA Approved: PAROXETINE HYDROCHLORIDE — Supplemental Application (Apotex Corp)

  FDA approved Apotex Corp's supplemental application for paroxetine hydrochloride (paroxetine HCl), confirming continued approval for the gen…

• FDA approval · 2008-10-31
  FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved an original generic application for sertraline hydrochloride by Rising Pharma Holdings, Inc., allowing a generic version of…

• FDA approval · 2008-08-18
  FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)

  FDA approved a supplemental application for fluoxetine submitted by Chartwell Governmental & Specialty RX, LLC.