Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-12-26FDA Approved: ZIPRASIDONE MESYLATE — Original Application (Fosun Pharma USA Inc.)
FDA approved the original application for ziprasidone mesylate (generic) to treat schizophrenia and bipolar I disorder.
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FDA approval · 2019-12-26FDA Approved: ARIPIPRAZOLE — Original Application (VistaPharm, LLC)
FDA approved VistaPharm, LLC's original ANDA (212870) for a generic aripiprazole. This approval makes a generic version of aripiprazole avai…
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FDA approval · 2019-12-22FDA Approved: RISPERIDONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)
FDA approved a supplemental application for risperidone by Jubilant Cadista Pharmaceuticals Inc. This approval pertains to changes to the ap…
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FDA approval · 2019-12-20FDA Approved: QUETIAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for quetiapine from Macleods Pharmaceuticals Limited. The action provides regulatory approval for th…
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FDA approval · 2019-12-20FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for quetiapine fumarate from Aurobindo Pharma Limited, allowing continued marketing of this generic …
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FDA approval · 2019-12-17FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)
The FDA approved a supplemental application from Alembic Pharmaceuticals Limited to manufacture and market lamotrigine chewable dispersible …
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FDA approval · 2019-12-11FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves Hikma Pharmaceuticals USA Inc.'s supplemental application for quetiapine fumarate, a generic formulation under ANDA 090749.
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FDA approval · 2019-12-11FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for Quetiapine Fumarate (ANDA 090120).
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FDA approval · 2019-12-10FDA Approved: ARIPIPRAZOLE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for ARIPIPRAZOLE from Amneal Pharmaceuticals LLC (aripiprazole).
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FDA approval · 2019-12-06FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)
FDA approves a supplemental application for the Lamotrigine Kit from OWP Pharmaceuticals, Inc., adding a lamotrigine kit product under an ap…
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FDA approval · 2019-12-06FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for lamotrigine from Aurobindo Pharma Limited under ANDA090401, indicating an updated or added appro…
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FDA approval · 2019-12-06FDA Approved: LAMOTRIGINE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Lamotrigine from Ascend Laboratories, LLC.
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FDA approval · 2019-11-29FDA Approved: ZIPRASIDONE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for ziprasidone submitted by Dr. Reddy's Laboratories Limited.
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FDA approval · 2019-11-29FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for ziprasidone hydrochloride from BluePoint Laboratories, authorizing its generic product to be mar…
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FDA approval · 2019-11-22FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application to introduce Depakote Sprinkles (divalproex sodium) from AbbVie, expanding the drug's dosage form op…
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FDA approval · 2019-11-22FDA Approved: QUETIAPINE — Supplemental Application (Accord Healthcare Inc.)
FDA approves a supplemental application for Quetiapine by Accord Healthcare Inc., granting regulatory approval for a generic version of the …
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FDA approval · 2019-11-21FDA Approved: LAMOTRIGINE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for lamotrigine by Torrent Pharmaceuticals Limited.
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FDA approval · 2019-11-21FDA Approved: LAMOTRIGINE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for lamotrigine from Actavis Pharma, Inc.
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FDA approval · 2019-11-12FDA Approved: RISPERIDONE — Supplemental Application (Ajanta Pharma USA Inc.)
The FDA approved Ajanta Pharma USA Inc.'s supplemental application for risperidone, authorizing a generic version of the antipsychotic.
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FDA approval · 2019-10-29FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for lamotrigine submitted by Zydus Pharmaceuticals USA Inc. The exact changes covered by the supplem…
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FDA approval · 2019-10-29FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for lamotrigine from Zydus Pharmaceuticals USA Inc.
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FDA approval · 2019-10-22FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for ZYPREXA Intramuscular (olanzapine) from Eli Lilly. The approval relates to a supplemental su…
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FDA approval · 2019-10-22FDA Approved: ZYPREXA — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for ZYPREXA (olanzapine) submitted by Eli Lilly and Company, resulting in updated labeling to re…
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FDA approval · 2019-10-18FDA Approved: DIVALPROEX SODIUM — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' divalproex sodium as a generic product under Original Application (ANDA 209286).
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FDA approval · 2019-10-11FDA Approved: SECUADO — Original Application (Noven Therapeutics, LLC)
FDA approved SECUADO (asenapine) from Noven Therapeutics in an original NDA (212268) for treatment of schizophrenia and acute manic/mixed ep…