Major Depressive Disorder

• FDA approval · 2006-10-05
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved Amneal Pharmaceuticals of New York's supplemental application for a generic form of bupropion hydrochloride, authorizing it…

• FDA approval · 2006-10-03
  FDA Approved: CITALOPRAM — Original Application (Cipla USA Inc.)

  FDA approves Cipla USA Inc.'s original application for Citalopram, granting permission to market a generic version of the antidepressant.

• FDA approval · 2006-09-20
  FDA Approved: SEROQUEL — Supplemental Application (H2-Pharma, LLC)

  The FDA approved a supplemental application for SEROQUEL (quetiapine) filed by H2-Pharma, LLC.

• FDA approval · 2006-09-14
  FDA Approved: EFFEXOR XR — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Effexor XR (venlafaxine hydrochloride) submitted by Viatris Specialty LLC.

• FDA approval · 2006-08-28
  FDA Approved: CITALOPRAM HYDROBROMIDE — Original Application (Aurobindo Pharma Limited)

  FDA approves the original application for a generic form of citalopram hydrobromide, manufactured by Aurobindo Pharma Limited.

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• 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 · 2006-08-03
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's venlafaxine hydrochloride as an original ANDA, making a generic version of venlafaxine hydrochloride available.

• FDA approval · 2006-08-02
  FDA Approved: TRIMIPRAMINE MALEATE — Original Application (Elite Laboratories, Inc.)

  FDA approved the original application for Trimipramine Maleate, a generic antidepressant manufactured by Elite Laboratories, Inc.

• EMA approval · 2006-07-27
  EMA Refused: Thymanax (agomelatine) — Les Laboratoires Servier

  The EMA refused approval for Thymanax (agomelatine) by Les Laboratoires Servier.

• FDA approval · 2006-07-21
  FDA Approved: MIRTAZAPINE — Supplemental Application (Aurolife Pharma LLC)

  FDA approved a supplemental application from Aurolife Pharma LLC to market a generic form of the antidepressant mirtazapine.

• FDA approval · 2006-07-03
  FDA Approved: WELLBUTRIN XL — Supplemental Application (Bausch Health US LLC)

  FDA approved a supplemental application for WELLBUTRIN XL (bupropion hydrochloride) from Bausch Health US LLC.

• FDA approval · 2006-07-03
  FDA Approved: WELLBUTRIN SR — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Wellbutrin SR (bupropion hydrochloride) from GlaxoSmithKline LLC.

• FDA approval · 2006-06-29
  FDA Approved: TRANYLCYPROMINE SULFATE — Original Application (Strides Pharma Science Limited)

  FDA approved a generic version of tranylcypromine sulfate for major depressive disorder under ANDA 040640, with Strides Pharma Science Limit…

• FDA approval · 2006-06-14
  FDA Approved: CITALOPRAM — Original Application (Chartwell Governmental & Specialty RX, LLC.)

  FDA approves the original application for generic citalopram, with Chartwell Governmental & Specialty RX, LLC as the manufacturer.

• FDA approval · 2006-05-19
  FDA Approved: DESIPRAMINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for desipramine hydrochloride from Actavis Pharma, Inc., authorizing continued marketing of the gene…

• FDA approval · 2006-05-19
  FDA Approved: DESIPRAMINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for desipramine hydrochloride from Actavis Pharma, Inc.

• FDA approval · 2006-05-19
  FDA Approved: DESIPRAMINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Desipramine Hydrochloride from Actavis Pharma, Inc. This action confirms regulatory approval…

• 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…