Premenstrual Dysphoric Disorder

• FDA approval · 2007-10-25
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride, a generic sertraline product, under the ANDA.

• FDA approval · 2007-10-10
  FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)

  FDA approved Lannett Company's supplemental application for fluoxetine hydrochloride, a generic version of fluoxetine.

• FDA approval · 2007-09-28
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for fluoxetine from Teva Pharmaceuticals USA, Inc., resulting in an approved label update for this g…

• FDA approval · 2007-08-02
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

  FDA approved a supplemental application for Prozac (fluoxetine hydrochloride) submitted by Dista Products Company.

• FDA approval · 2007-07-25
  FDA Approved: PAROXETINE — Original Application (NorthStar Rx LLC)

  FDA approves NorthStar Rx LLC's original ANDA for paroxetine hydrochloride (generic paroxetine).

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• FDA approval · 2007-05-24
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for fluoxetine, authorizing changes to the product's labeling.

• FDA approval · 2007-04-30
  FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (ScieGen Pharmaceuticals Inc)

  FDA approved ScieGen Pharmaceuticals Inc.'s sertraline hydrochloride as a generic under an Original Abbreviated New Drug Application for the…

• FDA approval · 2007-03-15
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

  The FDA approved a supplemental application for Prozac (fluoxetine hydrochloride) submitted by Dista Products Company.

• FDA approval · 2007-03-07
  FDA Approved: PAROXETINE — Original Application (Zydus Lifesciences Limited)

  FDA approves Zydus Lifesciences Limited's original application for paroxetine hydrochloride tablets (generic paroxetine). This approval prov…

• FDA approval · 2007-02-09
  FDA Approved: FLUOXETINE — Original Application (Lannett Company, Inc.)

  FDA approved the original application for a generic fluoxetine hydrochloride product from Lannett Company, Inc.

• FDA approval · 2007-02-06
  FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' sertraline hydrochloride as a generic drug via an Original ANDA approval.

• FDA approval · 2007-02-06
  FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved an Original Application (ANDA) for sertraline hydrochloride from Quallent Pharmaceuticals Health LLC, a generic version of sert…

• FDA approval · 2007-02-06
  FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  The FDA approved an original application for a generic sertraline hydrochloride product from Aurobindo Pharma Limited.

• FDA approval · 2007-02-05
  FDA Approved: PAROXETINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application from Apotex Corp. for paroxetine hydrochloride as a generic product. Paroxetine is used to treat maj…

• FDA approval · 2007-01-25
  FDA Approved: FLUOXETINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for fluoxetine filed by Dr. Reddy's Laboratories Limited.

• FDA approval · 2006-11-17
  FDA Approved: FLUOXETINE — Supplemental Application (TIME CAP LABORATORIES, INC.)

  The FDA approved a supplemental application for a fluoxetine hydrochloride product from Time Cap Laboratories, Inc., approving this generic …

• FDA approval · 2006-08-22
  FDA Approved: PAXIL — Supplemental Application (Apotex Corp)

  The FDA approved a supplemental application for Paxil (paroxetine hydrochloride) submitted by Apotex Corp.

• FDA approval · 2006-08-22
  FDA Approved: PAROXETINE HYDROCHLORIDE — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for Paroxetine hydrochloride submitted by Apotex Corp.

• FDA approval · 2006-08-11
  FDA Approved: SERTRALINE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved an original application for sertraline (generic) by Heritage Pharmaceuticals d/b/a Avet Pharmaceuticals.

• FDA approval · 2006-05-04
  FDA Approved: ZOLOFT — Supplemental Application (ROERIG)

  The FDA approved a supplemental application for Zoloft (sertraline hydrochloride) submitted by Roerig. The approval updates the product's la…