Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-01-22FDA Approved: HALOPERIDOL — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for Haloperidol lactate from Fresenius Kabi USA, LLC.
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FDA approval · 2025-01-22FDA Approved: RISPERIDONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for risperidone from Sun Pharmaceutical Industries, Inc., indicating an update to labeling or indica…
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FDA approval · 2025-01-22FDA Approved: SAPHRIS — Supplemental Application (Allergan, Inc.)
The FDA approved Allergan's supplemental application for SAPHRIS (asenapine), resulting in changes to the product labeling.
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FDA approval · 2025-01-22FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC.
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FDA approval · 2025-01-22FDA Approved: RYKINDO EXTENDED-RELEASE MICROSPHERES — Supplemental Application (Shandong Luye Pharmaceutical Co., Ltd.)
The FDA approved a supplemental application for RYKINDO Extended-Release Microspheres (risperidone) from Shandong Luye Pharmaceutical Co., L…
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FDA approval · 2025-01-22FDA Approved: HALOPERIDOL — Supplemental Application (AiPing Pharmaceutical, Inc)
FDA approved AiPing Pharmaceutical's supplemental application for haloperidol, a generic antipsychotic.
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FDA approval · 2025-01-22FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)
FDA approved a supplemental application for Risperdal M-Tab (risperidone) from Janssen Pharmaceuticals, Inc., updating the product under a s…
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FDA approval · 2025-01-22FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)
FDA approves a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC.
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FDA approval · 2025-01-22FDA Approved: HALOPERIDOL — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for HALOPERIDOL submitted by Lannett Company, Inc., authorizing changes to the product's approva…
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FDA approval · 2025-01-16FDA Approved: HALOPERIDOL LACTATE — Supplemental Application (Mylan Institutional LLC)
FDA granted a supplemental approval for HALOPERIDOL LACTATE to Mylan Institutional LLC, issuing a supplemental application for this generic …
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FDA approval · 2025-01-14FDA Approved: CARBAMAZEPINE — Original Application (Ascend Laboratories, LLC)
FDA approved a generic carbamazepine product from Ascend Laboratories, LLC under an Original Application (ANDA).
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FDA approval · 2025-01-13FDA Approved: HALOPERIDOL — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for HALOPERIDOL LACTATE, a generic injectable form of haloperidol from Fresenius Kabi USA, LLC.
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FDA approval · 2025-01-13FDA Approved: ARIPIPRAZOLE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA supplemental approval for ARIPIPRAZOLE by Amneal Pharmaceuticals LLC under an ANDA (ANDA 203906). This document records the supplemental…
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FDA approval · 2025-01-13FDA Approved: ARIPIPRAZOLE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for aripiprazole by VistaPharm, LLC (ANDA 212870). The authorization pertains to changes to the appr…
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FDA approval · 2025-01-13FDA Approved: CARBAMAZEPINE — Original Application (Torrent Pharmaceuticals Limited)
FDA approved Torrent Pharmaceuticals Limited's original application for a generic carbamazepine product.
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FDA approval · 2025-01-08FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for lamotrigine from Zydus Pharmaceuticals USA Inc. under an ANDA, indicating an approved change…
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FDA approval · 2024-12-26FDA Approved: LAMOTRIGINE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for lamotrigine by Amneal Pharmaceuticals LLC (ANDA 207497).
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EMA approval · 2024-12-18EMA Authorised: Zyprexa Velotab (olanzapine) — CHEPLAPHARM Registration GmbH
The EMA authorised Zyprexa Velotab, a generic olanzapine product, under CHEPLAPHARM Registration GmbH for schizophrenia and bipolar disorder…
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FDA approval · 2024-12-10FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Fresenius Kabi USA, LLC)
The FDA approved an original application for chlorpromazine hydrochloride from Fresenius Kabi USA, LLC, making this generic antipsychotic av…
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FDA approval · 2024-12-05FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
The FDA approved a supplemental application for divalproex sodium submitted by Unichem Pharmaceuticals (USA), Inc. under ANDA079163. This ac…
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FDA approval · 2024-12-03FDA Approved: LURASIDONE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for lurasidone hydrochloride from Amneal Pharmaceuticals LLC, supporting the generic product's conti…
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FDA approval · 2024-11-26FDA Approved: OLANZAPINE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Ascend Laboratories, LLC to market a generic olanzapine product under an ANDA. This marks the cl…
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FDA approval · 2024-11-18FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Macleods Pharmaceuticals Limited)
The FDA approved a supplemental application for Quetiapine fumarate by Macleods Pharmaceuticals Limited, enabling a generic version of the a…
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FDA approval · 2024-11-18FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved chlorpromazine hydrochloride as a generic product under an original ANDA for Camber Pharmaceuticals.
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FDA approval · 2024-11-12FDA Approved: ARIPIPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for a generic form of aripiprazole from Aurobindo Pharma Limited.