Major Depressive Disorder

• FDA approval · 2021-02-01
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Inc)

  FDA approves Dr. Reddy's Laboratories' supplemental application to add a generic aripiprazole orally disintegrating tablet.

• FDA approval · 2021-01-22
  FDA Approved: TRINTELLIX — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for TRINTELLIX (vortioxetine) submitted by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2021-01-21
  FDA Approved: FLUOXETINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for fluoxetine submitted by Alembic Pharmaceuticals Limited.

• FDA approval · 2021-01-04
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Bupropion Hydrochloride from Amneal Pharmaceuticals of New York LLC, authorizing the generic pro…

• FDA approval · 2021-01-04
  FDA Approved: BUPROPION HYDROCHLORIDE (SR) — Supplemental Application (Cipla USA Inc.,)

  The FDA approved Cipla USA Inc.'s supplemental application for Bupropion hydrochloride sustained-release, enabling the generic product to be…

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• FDA approval · 2020-12-31
  FDA Approved: BUPROPION HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's generic bupropion hydrochloride under an Original Application (ANDA).

• FDA approval · 2020-12-30
  FDA Approved: DULOXETINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for duloxetine (ANDA204343), enabling the continued marketing of the gener…

• FDA approval · 2020-12-23
  FDA Approved: FLUOXETINE — Supplemental Application (Cadila Pharmaceuticals Limited)

  FDA approved a supplemental application for Fluoxetine from Cadila Pharmaceuticals Limited, enabling the marketing of this generic fluoxetin…

• FDA approval · 2020-12-22
  FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Dr. Reddys Laboratories Inc.)

  The FDA approved a supplemental application for Bupropion Hydrochloride SR, granting approval for the generic sustained-release formulation …

• FDA approval · 2020-12-21
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2020-12-21
  FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Slate Run Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Bupropion hydrochloride sustained-release by Slate Run Pharmaceuticals, LLC.

• FDA approval · 2020-11-30
  FDA Approved: BUPROPION HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' generic Bupropion hydrochloride under an original application.

• FDA approval · 2020-11-13
  FDA Approved: TRINTELLIX — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for TRINTELLIX (vortioxetine) by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2020-11-04
  FDA Approved: MIRTAZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Mirtazapine from Mylan Pharmaceuticals (ANDA 076122).

• FDA approval · 2020-11-03
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for venlafaxine hydrochloride (generic) under ANDA076565, enabling it…

• FDA approval · 2020-10-30
  FDA Approved: QUETIAPINE EXTENDED RELEASE — Supplemental Application (ACI Healthcare USA, Inc.)

  FDA approves a supplemental application for a generic quetiapine extended-release product by ACI Healthcare USA, Inc.

• FDA approval · 2020-10-29
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (CIPLA USA INC.,)

  FDA approved a supplemental application for BUPROPION HYDROCHLORIDE from CIPLA USA INC., updating the existing approved product.

• FDA approval · 2020-10-21
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (XLCare Pharmaceuticals, Inc.)

  FDA approved the generic venlafaxine hydrochloride (venlafaxine) under Original Application for the treatment of major depressive disorder, …

• FDA approval · 2020-10-16
  FDA Approved: BUPROPION HYDROCHLORIDE XL — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for BUPROPION HYDROCHLORIDE XL by Actavis Pharma, Inc. under the ANDA process for the extended-relea…

• FDA approval · 2020-10-07
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for bupropion hydrochloride from Actavis Pharma, Inc., indicating an approved change to the gene…

• FDA approval · 2020-10-01
  FDA Approved: CYMBALTA — Supplemental Application (Eli Lilly and Company)

  FDA approves a supplemental application for Cymbalta (duloxetine hydrochloride) submitted by Eli Lilly and Company.

• FDA approval · 2020-09-28
  FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Slate Run Pharmaceuticals, LLC)

  FDA approves a supplemental application for Bupropion Hydrochloride Sustained-Release, submitted by Slate Run Pharmaceuticals, LLC.

• FDA approval · 2020-08-07
  FDA Approved: CLOMIPRAMINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for clomipramine hydrochloride (generic) from Rising Pharma Holdings, Inc., enabling a generic product…

• FDA approval · 2020-07-31
  FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)

  FDA approved a supplemental application for SPRAVATO (esketamine hydrochloride) submitted by Janssen Pharmaceuticals Inc.

• FDA approval · 2020-07-28
  FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Contract Pharmacal Corp.)

  FDA approved an original application for doxepin hydrochloride, a generic product from Contract Pharmacal Corp., with labeling for major dep…