Obsessive-compulsive Disorder

• 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 · 2009-02-27
  FDA Approved: FLUVOXAMINE MALEATE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for fluvoxamine maleate (generic) submitted by Chartwell RX, LLC.

• 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.

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

  FDA approved a supplemental application from Apotex Corp for Paxil (paroxetine hydrochloride), authorizing a generic version under the exist…

• FDA approval · 2009-01-30
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

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

• 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 · 2008-10-22
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for fluoxetine from Teva Pharmaceuticals USA, Inc., indicating a modification to the product's a…

• FDA approval · 2008-09-25
  FDA Approved: FLUOXETINE — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approved a supplemental application for Fluoxetine hydrochloride from Quallent Pharmaceuticals Health LLC.

• 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.

• FDA approval · 2008-08-18
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental ANDA for Fluoxetine by Teva Pharmaceuticals USA, Inc., authorizing a generic version of fluoxetine. The action f…

• FDA approval · 2008-07-16
  FDA Approved: SERTRALINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approves a supplemental abbreviated new drug application (ANDA) for sertraline from Heritage Pharmaceuticals d/b/a Avet Pharmaceuticals …

• FDA approval · 2008-07-02
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for sertraline hydrochloride (generic sertraline), authorizing the a…

• FDA approval · 2008-06-25
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for sertraline hydrochloride manufactured by Aurobindo Pharma Limited.

• FDA approval · 2008-05-29
  FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for a generic fluoxetine hydrochloride product from Lannett Company, Inc. under anANDA, confirming r…

• FDA approval · 2008-05-20
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for paroxetine hydrochloride/paroxetine from Zydus Lifesciences Limited, authorizing a generic parox…

• FDA approval · 2008-04-17
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for fluoxetine by Teva Pharmaceuticals USA, Inc. The approval updates the product labeling and/o…

• FDA approval · 2008-03-21
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

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

• FDA approval · 2008-03-13
  FDA Approved: PAROXETINE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved a generic paroxetine product (paroxetine hydrochloride hemihydrate) from Mylan Pharmaceuticals Inc. under an original ANDA.

• FDA approval · 2008-03-09
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

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

• FDA approval · 2008-03-06
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for sertraline hydrochloride from Mylan Pharmaceuticals Inc., indicating approval of a supplemen…

• FDA approval · 2008-02-14
  FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)

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

• FDA approval · 2008-02-05
  FDA Approved: PAROXETINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Apotex Corp. to market a generic paroxetine hydrochloride product (PAROXETINE HYDROCHLORIDE).