Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-01-16FDA Approved: VALPROIC ACID — Supplemental Application (QUAGEN PHARMACEUTICALS LLC)
FDA approves a supplemental application for Valproic acid from Quagen Pharmaceuticals LLC (ANDA 090517).
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FDA approval · 2015-01-12FDA Approved: RISPERIDONE — Original Application (Chartwell RX, LLC)
FDA approved Chartwell RX, LLC's generic risperidone through an original ANDA submission, marking the first approval of this generic product…
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FDA approval · 2015-01-07FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for Depakote ER (divalproex sodium) filed by AbbVie Inc., resulting in a regulatory update to th…
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FDA approval · 2014-12-30FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for LAMICTAL (lamotrigine) from GlaxoSmithKline, updating the product labeling as a result of the su…
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FDA approval · 2014-12-30FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for LAMICTAL XR (lamotrigine) from GlaxoSmithKline LLC, updating the extended-release formulatio…
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FDA approval · 2014-12-20FDA Approved: OLANZAPINE — Supplemental Application (Dr. Reddy's Laboratories Ltd.)
FDA approved Dr. Reddy's Laboratories Ltd.'s supplemental application for olanzapine, enabling a generic olanzapine product.
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FDA approval · 2014-12-19FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for a generic olanzapine and fluoxetine fixed-dose product, expanding access to the olanzapine/…
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FDA approval · 2014-12-19FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's supplemental application for a generic fixed-dose combination of olanzapine and fluoxetine (olanzapine and fluoxetine).
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FDA approval · 2014-12-13FDA Approved: LAMOTRIGINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Lamotrigine by Sun Pharmaceutical Industries, Inc.
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FDA approval · 2014-12-12FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for lamotrigine from Aurobindo Pharma Limited, reflecting changes to labeling for this generic produ…
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FDA approval · 2014-12-12FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved a supplemental application for lamotrigine from Alembic Pharmaceuticals Limited under an ANDA. This confirms approval of a supp…
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FDA approval · 2014-12-10FDA Approved: LAMOTRIGINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
FDA granted a supplemental approval for Lamotrigine from Unichem Pharmaceuticals (USA), Inc. under an ANDA supplemental application. The sni…
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FDA approval · 2014-12-10FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)
The FDA approved Viatris Specialty LLC's supplemental application for Geodon (ziprasidone mesylate).
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FDA approval · 2014-12-10FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)
FDA approved a supplemental application to authorize a Lamotrigine Kit from OWP Pharmaceuticals, Inc., expanding the approved lamotrigine pr…
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FDA approval · 2014-12-10FDA Approved: LAMOTRIGINE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)
FDA approved a supplemental application for lamotrigine from Jubilant Cadista Pharmaceuticals Inc. This marks an approval of a generic lamot…
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FDA approval · 2014-12-08FDA Approved: OLANZAPINE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for a generic olanzapine product from Aurobindo Pharma Limited.
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FDA approval · 2014-12-08FDA Approved: OLANZAPINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for olanzapine submitted by Teva Pharmaceuticals USA, Inc.
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FDA approval · 2014-12-08FDA Approved: OLANZAPINE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)
FDA approves Jubilant Cadista Pharmaceuticals Inc.'s supplemental application for olanzapine, enabling a generic olanzapine product.
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FDA approval · 2014-12-05FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for lamotrigine by Aurobindo Pharma Limited, authorizing changes to an existing lamotrigine product.
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FDA approval · 2014-11-28FDA Approved: RISPERIDONE — Supplemental Application (Natco Pharma USA LLC)
The FDA approved a supplemental application for risperidone from Natco Pharma USA LLC under an ANDA, enabling continued marketing of a gener…
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FDA approval · 2014-11-20FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) submitted by AbbVie Inc.
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FDA approval · 2014-11-20FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Ltd)
FDA approved a supplemental application for divalproex sodium from Dr. Reddy's Laboratories Ltd.
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FDA approval · 2014-11-20FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for DEPAKOTE ER (divalproex sodium) submitted by AbbVie Inc.
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FDA approval · 2014-11-18FDA Approved: SAPHRIS — Supplemental Application (Allergan, Inc.)
The FDA approved Allergan's supplemental application for SAPHRIS (asenapine) to update its labeling, reflecting an expanded or clarified ind…
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FDA approval · 2014-10-30FDA Approved: QUETIAPINE — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s supplemental application for quetiapine, enabling the marketing of a generic quetiapine product. The a…