Major Depressive Disorder
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2025-06-24FDA Approved: RALDESY TM — Supplemental Application (Validus Pharmaceuticals LLC)
FDA approved a supplemental application for RALDESY TM (trazodone hydrochloride oral) from Validus Pharmaceuticals LLC, indicating a supplem…
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FDA label_change · 2024-07-03FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)
The FDA approved a supplemental application for Bupropion hydrochloride from Granules Pharmaceuticals Inc., resulting in an approved change …
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FDA label_change · 2024-06-12FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for PAROXETINE HYDROCHLORIDE submitted by Zydus Lifesciences Limited, resulting in changes to the pr…
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FDA label_change · 2023-10-10FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Apnar Pharma LP)
The FDA approved a supplemental application for bupropion hydrochloride from Apnar Pharma LP, indicating an approved change to an existing p…
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FDA label_change · 2023-08-23FDA Approved: TRINTELLIX — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Trintellix (vortioxetine) submitted by Takeda Pharmaceuticals America, Inc., which appears t…
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FDA label_change · 2023-08-18FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)
FDA approved a supplemental application for Fluoxetine to update the labeling. The applicant is Chartwell Governmental & Specialty RX, LLC.
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FDA label_change · 2023-08-18FDA Approved: VENLAFAXINE — Supplemental Application (Alembic Pharmaceuticals Inc.)
The FDA approved a supplemental application for venlafaxine from Alembic Pharmaceuticals, resulting in labeling updates for the generic prod…
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FDA label_change · 2022-08-30FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for a sertraline hydrochloride generic from Quallent Pharmaceuticals Health LLC, updating the labeli…
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FDA label_change · 2021-09-21FDA Approved: FLUOXETINE — Supplemental Application (ScieGen Pharmaceuticals, Inc)
FDA approved a supplemental application for fluoxetine by ScieGen Pharmaceuticals to update the labeling for this generic antidepressant.
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FDA label_change · 2021-09-20FDA Approved: ZOLOFT — Supplemental Application (ROERIG)
FDA approved a supplemental application for Zoloft (sertraline hydrochloride) submitted by Roerig to update the product labeling.
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FDA label_change · 2021-09-20FDA Approved: DESVENLAFAXINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA action on Sun Pharmaceutical's supplemental application for desvenlafaxine, likely updating labeling or expanding indications. The submi…
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FDA label_change · 2021-09-20FDA Approved: VENLAFAXINE — Supplemental Application (Alembic Pharmaceuticals Inc.)
FDA notice of a supplemental labeling application for VENLAFAXINE by Alembic Pharmaceuticals Inc.
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FDA label_change · 2020-09-25FDA Approved: MIRTAZAPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for mirtazapine from Sun Pharmaceutical Industries, resulting in labeling updates.
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FDA label_change · 2020-03-27FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for SEROQUEL XR (quetiapine) from AstraZeneca, resulting in labeling updates for the drug.
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FDA label_change · 2020-02-05FDA Approved: SEROQUEL — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for SEROQUEL (quetiapine) submitted by H2-Pharma, LLC, affecting the product labeling. The action re…
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FDA label_change · 2019-11-05FDA Approved: WELLBUTRIN SR — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for Wellbutrin SR, updating the labeling for the bupropion extended-release formulation following Gl…
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FDA label_change · 2018-08-13FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for venlafaxine hydrochloride filed by Macleods Pharmaceuticals Limited. The approval is associated …
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FDA label_change · 2017-06-22FDA Approved: QUETIAPINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's supplemental application for quetiapine (generic), updating the drug's labeling under the approved ANDA.
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FDA label_change · 2017-04-11FDA Approved: TRINTELLIX — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Trintellix (vortioxetine) from Takeda Pharmaceuticals America, updating the product labeling…
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FDA label_change · 2017-01-04FDA Approved: EFFEXOR XR — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental labeling change for Effexor XR (venlafaxine hydrochloride) submitted by Viatris Specialty LLC. The supplemental …
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FDA label_change · 2017-01-04FDA Approved: FETZIMA — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for FETZIMA (levomilnacipran hydrochloride) from Allergan, Inc., authorizing a change to its labelin…
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FDA label_change · 2016-12-28FDA Approved: FLUOXETINE — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for fluoxetine from Dr. Reddy's Laboratories Limited, indicating a labeling-related update to the ge…
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FDA label_change · 2016-09-09FDA Approved: DESVENLAFAXINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for desvenlafaxine, resulting in labeling changes.
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FDA label_change · 2016-09-06FDA Approved: VIIBRYD — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for VIIBRYD (vilazodone hydrochloride) from Allergan, Inc.—updating the drug's labeling. This action…
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FDA label_change · 2016-08-30FDA Approved: APLENZIN — Supplemental Application (Bausch Health US, LLC)
The FDA notes a supplemental application submission for APLENZIN (bupropion hydrobromide) from Bausch Health US, LLC, related to the product…