Major Depressive Disorder

• 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 · 2007-09-20
  FDA Approved: EFFEXOR XR — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2007-09-17
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Amneal's supplemental ANDA for generic bupropion hydrochloride, enabling marketing of a generic formulation.

• FDA approval · 2007-08-22
  FDA Approved: MIRTAZAPINE — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s generic mirtazapine tablet under an original Abbreviated New Drug Application (ANDA077666).

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• 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 · 2007-08-02
  FDA Approved: TRANYLCYPROMINE SULFATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Tranylcypromine Sulfate from Actavis Pharma, Inc. (Tranylcypromine Sulfate).

• FDA approval · 2007-08-02
  FDA Approved: PHENELZINE SULFATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for phenelzine sulfate, an MAOI antidepressant, expanding regulatory approval for this product.

• FDA approval · 2007-08-01
  FDA Approved: EFFEXOR XR — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2007-07-30
  FDA Approved: EMSAM — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for EMSAM (selegiline) submitted by Viatris Specialty LLC.

• 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).

• FDA approval · 2007-07-12
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for venlafaxine hydrochloride submitted by Teva Pharmaceuticals USA, Inc. The approval updates t…

• FDA approval · 2007-07-11
  FDA Approved: DOXEPIN HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental ANDA for doxepin hydrochloride from Mylan Pharmaceuticals Inc., enabling a generic version of the drug to en…

• FDA approval · 2007-07-03
  FDA Approved: AMOXAPINE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for AMOXAPINE submitted by Actavis Pharma, Inc.

• FDA approval · 2007-07-02
  FDA Approved: CITALOPRAM HYDROBROMIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Citalopram hydrobromide (generic) from Aurobindo Pharma Limited under ANDA077812. This expands a…

• FDA approval · 2007-07-02
  FDA Approved: CITALOPRAM — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)

  The FDA approved a supplemental application for the generic antidepressant citalopram submitted by Chartwell Governmental & Specialty RX, LL…

• FDA approval · 2007-06-29
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Amitriptyline hydrochloride from Sandoz Inc., enabling regulatory clearance for this generic pro…

• FDA approval · 2007-06-28
  FDA Approved: CITALOPRAM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Citalopram hydrobromide from Aurobindo Pharma Limited.

• FDA approval · 2007-06-28
  FDA Approved: CITALOPRAM — Supplemental Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s supplemental application for citalopram.

• FDA approval · 2007-06-27
  FDA Approved: CITALOPRAM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for the generic antidepressant citalopram from Mylan Pharmaceuticals. This approval enables the gene…

• FDA approval · 2007-06-26
  FDA Approved: TRAZODONE HYDROCHLORIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application for trazodone hydrochloride from Oxford Pharmaceuticals, LLC.

• FDA approval · 2007-06-26
  FDA Approved: DOXEPIN HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for doxepin hydrochloride from Lannett Company, Inc., authorizing changes to an already approved pro…

• FDA approval · 2007-06-26
  FDA Approved: TRAZODONE HYDROCHLORIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application for trazodone hydrochloride submitted by Oxford Pharmaceuticals, LLC.

• FDA approval · 2007-06-25
  FDA Approved: IMIPRAMINE HYDROCHLORIDE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for imipramine hydrochloride from Strides Pharma Science Limited. The approval covers the continued …

• FDA approval · 2007-06-25
  FDA Approved: TRAZODONE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for trazodone hydrochloride (Teva Pharmaceuticals USA, Inc.) under the ANDA program. This action upd…