Major Depressive Disorder

• FDA approval · 2024-08-29
  FDA Approved: PAROXETINE — Supplemental Application (Modavar Pharmaceuticals LLC)

  The FDA approved a supplemental application for paroxetine from Modavar Pharmaceuticals LLC.

• FDA approval · 2024-08-29
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved the supplemental application for Fluoxetine Hydrochloride from Taro Pharmaceuticals U.S.A., Inc. (ANDA211477), enabling the mar…

• FDA approval · 2024-08-27
  FDA Approved: TRAZODONE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for trazodone hydrochloride (generic) from Rising Pharma Holdings, Inc., confirming a generic version …

• FDA approval · 2024-08-26
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Bupropion Hydrochloride from Sun Pharmaceutical Industries, Inc., confirming a generic version o…

• FDA approval · 2024-08-16
  FDA Approved: DESVENLAFAXINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for desvenlafaxine submitted by Actavis Pharma, Inc., indicating an approved update to the product's…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2024-08-16
  FDA Approved: DESVENLAFAXINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved Alembic Pharmaceuticals Limited's supplemental application for desvenlafaxine succinate (desvenlafaxine) under ANDA204003.

• FDA approval · 2024-08-12
  FDA Approved: VENLAFAXINE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for venlafaxine submitted by Ascend Laboratories, LLC.

• FDA approval · 2024-07-29
  FDA Approved: CITALOPRAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a citalopram hydrobromide product manufactured by Aurobindo Pharma Limited.

• FDA approval · 2024-07-25
  FDA Approved: DOXEPIN — Original Application (Aurobindo Pharma Limited)

  FDA approved the original ANDA for doxepin from Aurobindo Pharma Limited, granting approval for a generic doxepin product.

• FDA approval · 2024-07-11
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Camber Pharmaceuticals’ generic Bupropion hydrochloride under an ANDA, authorizing a modificatio…

• EMA approval · 2024-07-09
  EMA Authorised: Cymbalta (duloxetine) — Eli Lilly Nederland B.V.

  Cymbalta (duloxetine) has been authorized by the EMA for anxiety disorders, diabetic neuropathy, and major depressive disorder with Eli Lill…

• EMA approval · 2024-07-09
  EMA Authorised: Duloxetine Lilly (duloxetine) — Eli Lilly Nederland B.V.

  The European Medicines Agency authorised duloxetine (Lilly) by Eli Lilly Nederland B.V. for neuralgia, diabetic neuropathies, and major depr…

• FDA approval · 2024-07-01
  FDA Approved: DOXEPIN — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original application for doxepin (Doxepin), a generic antidepressant/tricyclic used for depression, an…

• FDA approval · 2024-06-24
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (Lifestar Pharma LLC)

  FDA approved a supplemental application for Amitriptyline Hydrochloride by Lifestar Pharma LLC. The submission status is AP.

• FDA approval · 2024-06-14
  FDA Approved: TRANYLCYPROMINE SULFATE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Tranylcypromine sulfate by Strides Pharma Science Limited.

• FDA approval · 2024-06-06
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' Venlafaxine hydrochloride as an original-application generic (ANDA 217767). Venlafaxine HCl is indicat…

• FDA approval · 2024-05-30
  FDA Approved: ESCITALOPRAM OXALATE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' supplemental application for escitalopram oxalate, enabling a generic version to be marketed.

• FDA approval · 2024-05-29
  FDA Approved: VILAZODONE HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for Vilazodone hydrochloride by Alembic Pharmaceuticals Limited. The action pertains to the generic …

• FDA approval · 2024-05-29
  FDA Approved: AMOXAPINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Amoxapine submitted by Chartwell RX, LLC.

• FDA approval · 2024-05-28
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved a supplemental application for aripiprazole submitted by Alembic Pharmaceuticals Inc., authorizing a modification to the pr…

• FDA approval · 2024-05-07
  FDA Approved: BUPROPION HYDROCHLORIDE (SR) — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved ScieGen Pharmaceuticals' supplemental application for a generic bupropion hydrochloride sustained-release product, expanding ac…

• FDA approval · 2024-05-07
  FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for Bupropion Hydrochloride SR from Epic Pharma, LLC (ANDA216766). This action reflects an approved …

• FDA approval · 2024-05-07
  FDA Approved: REXULTI — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental application for Rexulti (brexpiprazole) by Otsuka America Pharmaceutical, Inc.

• FDA approval · 2024-05-07
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Apnar Pharma LP)

  The FDA approved a supplemental application for a generic form of bupropion hydrochloride from Apnar Pharma LP, allowing continued marketing…

• FDA approval · 2024-05-07
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Bupropion hydrochloride from Micro Labs Limited under ANDA207403, signaling regulatory approval …