Post-traumatic Stress Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-03-26FDA Approved: PAROXETINE — Supplemental Application (Alembic Pharmaceuticals Inc.)
The FDA approved Alembic Pharmaceuticals Inc.'s supplemental application for paroxetine (generic). This marks approval of a generic paroxeti…
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FDA approval · 2026-01-28FDA Approved: SERTRALINE HCL — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approves Amneal's generic sertraline hydrochloride tablet via an original ANDA. This decision enables generic competition for sertraline…
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FDA approval · 2026-01-20FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Dr. Reddy's Laboratories Inc.)
FDA-approved original application for sertraline hydrochloride generic (Dr. Reddy's Laboratories) for multiple indications.
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FDA approval · 2026-01-20FDA Approved: SERTRALINE HCL — Original Application (Biocon Pharma Inc.)
FDA approved Biocon Pharma Inc.'s sertraline hydrochloride generic (SERTRALINE HCL) under ANDA218342, expanding access to the generic formul…
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FDA approval · 2025-11-20FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for sertraline hydrochloride manufactured by Aurobindo Pharma Limited. This approval covers a generi…
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FDA approval · 2025-09-24FDA Approved: PAROXETINE — Original Application (Alembic Pharmaceuticals Inc.)
FDA approves Alembic Pharmaceuticals Inc. Paroxetine Original Application for a generic paroxetine product.
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FDA approval · 2025-03-13FDA Approved: PAROXETINE — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for paroxetine hydrochloride (paroxetine) as a generic product under NorthStar Rx LLC's ANDA.
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FDA approval · 2025-02-28FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for paroxetine hydrochloride from Zydus Lifesciences Limited, adding regulatory approval for this ge…
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FDA approval · 2025-02-15FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (XLCare Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Sertraline Hydrochloride from XLCare Pharmaceuticals, Inc., authorizing the generic product.
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FDA approval · 2025-02-11FDA Approved: PAROXETINE — Supplemental Application (Padagis US LLC)
FDA approved a supplemental application for paroxetine (Padagis US LLC), updating the labeling to reflect expanded indications for the antid…
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FDA approval · 2025-01-29FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride (generic sertraline), authorizing the generic prod…
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FDA approval · 2024-11-07FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for Accord Healthcare's sertraline hydrochloride, a generic version of sertraline, maintaining the u…
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FDA approval · 2024-08-29FDA Approved: PAROXETINE — Supplemental Application (Modavar Pharmaceuticals LLC)
The FDA approved a supplemental application for paroxetine from Modavar Pharmaceuticals LLC.
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FDA approval · 2024-02-02FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for sertraline hydrochloride from Rising Pharma Holdings, Inc., resulting in approval of a gener…
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FDA approval · 2024-01-19FDA Approved: PAROXETINE — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for Paroxetine by ANI Pharmaceuticals, Inc., indicating approval of a generic product under ANDA 215…
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FDA approval · 2023-09-22FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application for sertraline hydrochloride from Granules Pharmaceuticals Inc. The action confirms continued approv…
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FDA approval · 2023-08-18FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for sertraline hydrochloride (generic) manufactured by Mylan Pharmaceuticals Inc.
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FDA approval · 2023-08-18FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Alvogen, Inc.)
FDA approved a supplemental application for sertraline hydrochloride (Alvogen), resulting in labeling changes to the approved NDA.
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FDA approval · 2023-08-18FDA Approved: PAROXETINE — Supplemental Application (Padagis US LLC)
The FDA approved a supplemental application for paroxetine submitted by Padagis US LLC. This action represents an additional regulatory appr…
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FDA approval · 2023-03-31FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application for Granules Pharmaceuticals' sertraline hydrochloride generic product, enabling its marketing in th…
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FDA approval · 2023-03-23FDA Approved: PAROXETINE — Supplemental Application (Modavar Pharmaceuticals LLC)
FDA approved a supplemental application for generic paroxetine filed by Modavar Pharmaceuticals LLC under ANDA212645.
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FDA approval · 2023-01-31FDA Approved: PAROXETINE — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for paroxetine from ANI Pharmaceuticals, indicating an approved change to the product (e.g., lab…
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FDA approval · 2023-01-25FDA Approved: ZOLOFT — Supplemental Application (ROERIG)
The FDA approved a supplemental application for Zoloft (sertraline hydrochloride) filed by Roerig.
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FDA approval · 2022-12-05FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA has approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride, allowing the generic to be marketed as part o…
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FDA approval · 2022-08-30FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride as a generic, confirming approval under the ANDA p…