Major Depressive Disorder

• FDA approval · 2021-08-04
  FDA Approved: CLOMIPRAMINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Inc.)

  The FDA approved Alembic Pharmaceuticals' generic clomipramine hydrochloride through an original ANDA.

• FDA approval · 2021-08-03
  FDA Approved: ESCITALOPRAM OXALATE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for escitalopram oxalate, a generic antidepressant product. This constitutes a…

• FDA approval · 2021-07-23
  FDA Approved: DRIZALMA SPRINKLE — Supplemental Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)

  The FDA approved a supplemental application for Drizalma Sprinkle, a duloxetine product, expanding the label to include a sprinkle-form dosa…

• FDA approval · 2021-07-07
  FDA Approved: DESIPRAMINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the original application for DESIPRAMINE HYDROCHLORIDE tablets from Alembic Pharmaceuticals Limited. The product is indicated f…

• FDA approval · 2021-07-06
  FDA Approved: MIRTAZAPINE — Supplemental Application (Aurolife Pharma LLC)

  FDA approved a supplemental application for Mirtazapine from Aurolife Pharma LLC.

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• FDA approval · 2021-06-30
  FDA Approved: VENLAFAXINE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved the original application for venlafaxine from Dr. Reddy's Laboratories, making a generic version of the antidepressant availabl…

• FDA approval · 2021-06-10
  FDA Approved: VENLAFAXINE — Original Application (Ascend Laboratories, LLC)

  FDA approved a generic venlafaxine product from Ascend Laboratories, LLC under Original Application (ANDA).

• FDA approval · 2021-06-07
  FDA Approved: TRAZODONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for trazodone hydrochloride from Sun Pharmaceutical Industries, indicating an updated regulatory…

• FDA approval · 2021-05-19
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Amitriptyline hydrochloride as an original-application generic from Unichem Pharmaceuticals (USA), Inc. (ANDA 214548).

• FDA approval · 2021-05-03
  FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (XLCare Pharmaceuticals, Inc.)

  FDA approved the original application for sertraline hydrochloride generic by XLCare Pharmaceuticals, enabling a generic version to be marke…

• FDA approval · 2021-04-27
  FDA Approved: VILAZODONE HYDROCHLORIDE — Original Application (Accord Healthcare Inc.)

  FDA approved Vilazodone hydrochloride from Accord Healthcare as an original ANDA, providing a generic option for the antidepressant Vilazodo…

• FDA approval · 2021-04-19
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for fluoxetine from Teva Pharmaceuticals USA, Inc., updating the generic's labeling under the AN…

• FDA approval · 2021-04-07
  FDA Approved: VILAZODONE HYDROCHLORIDE — Original Application (Exelan Pharmaceuticals Inc.)

  The FDA approved Exelan Pharmaceuticals’ original Abbreviated New Drug Application for vilazodone hydrochloride, establishing a generic vers…

• FDA approval · 2021-03-16
  FDA Approved: DESIPRAMINE HYDROCHLORIDE — Supplemental Application (Ingenus Pharmaceuticals, LLC)

  FDA approved a supplemental application for desipramine hydrochloride submitted by Ingenus Pharmaceuticals, LLC.

• FDA approval · 2021-03-12
  FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Solco Healthcare US LLC)

  The FDA approved a supplemental application for a generic version of Bupropion hydrochloride sustained-release from Solco Healthcare US LLC …

• FDA approval · 2021-03-09
  FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Leading Pharma, LLC)

  FDA approved the original application for doxepin hydrochloride (generic) from Leading Pharma, LLC, for use in treating depressive disorders…

• FDA approval · 2021-02-26
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for the generic olanzapine/fluoxetine combination, expanding access to this treatment.

• FDA approval · 2021-02-26
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for a generic olanzapine and fluoxetine product. The combination is indicated for depressive ep…

• FDA approval · 2021-02-24
  FDA Approved: NORTRIPTYLINE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved an original application for Nortriptyline Hydrochloride as a generic product by Zydus Lifesciences Limited.

• FDA approval · 2021-02-19
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Original Application (Lifestar Pharma LLC)

  FDA-approved Amitriptyline hydrochloride as a generic product via Original Application by Lifestar Pharma LLC.

• FDA approval · 2021-02-16
  FDA Approved: PAROXETINE — Original Application (Westminster Pharmaceuticals, LLC)

  The FDA approved Westminster Pharmaceuticals' generic paroxetine (PAROXETINE) via an Original Application (ANDA213485). It covers indication…

• FDA approval · 2021-02-06
  FDA Approved: PAXIL — Supplemental Application (Apotex Corp)

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

• FDA approval · 2021-02-05
  FDA Approved: CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA supplemental approval for a generic chlordiazepoxide and amitriptyline hydrochloride product from Mylan Pharmaceuticals.

• FDA approval · 2021-02-04
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for a generic fixed-dose combination of olanzapine and fluoxetine from Par Health USA, LLC. The …

• FDA approval · 2021-02-01
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for ARIPIPRAZOLE from Alembic Pharmaceuticals Inc., authorizing a generic aripiprazole product. The …