Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-07-23FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)
FDA approved a supplemental application for Zyprexa Intramuscular (olanzapine) from Eli Lilly, adding the intramuscular formulation to the p…
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FDA approval · 2015-06-19FDA Approved: LAMOTRIGINE EXTENDED RELEASE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for Lamotrigine Extended Release, adding an extended-release formulation to the approved lamotrigine…
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FDA approval · 2015-06-08FDA Approved: LITHIUM CARBONATE — Original Application (Alembic Pharmaceuticals Inc.)
FDA approved a generic lithium carbonate product from Alembic Pharmaceuticals Inc. via an original ANDA.
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FDA approval · 2015-05-29FDA Approved: DIVALPROEX SODIUM — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal's generic divalproex sodium product through an Original Application (ANDA 203730).
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FDA approval · 2015-05-18FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for Lamictal (lamotrigine) submitted by GlaxoSmithKline LLC. The action supplements the original…
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FDA approval · 2015-05-18FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for Lamictal ODT (lamotrigine) submitted by GlaxoSmithKline LLC. The approval concerns the supplemen…
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FDA approval · 2015-05-11FDA Approved: LITHOBID — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Lithobid (lithium carbonate) submitted by ANI Pharmaceuticals, Inc.
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FDA approval · 2015-04-28FDA Approved: ARIPIPRAZOLE — Original Application (Alembic Pharmaceuticals Inc.)
FDA approved Alembic's original ANDA for aripiprazole, a generic version of the antipsychotic.
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FDA approval · 2015-04-28FDA Approved: ARIPIPRAZOLE — Original Application (Exelan Pharmaceuticals, Inc.)
FDA approved a generic aripiprazole tablet under ANDA205064 for Exelan Pharmaceuticals, authorizing sale for the same indications as the bra…
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FDA approval · 2015-04-23FDA Approved: RISPERIDONE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for risperidone from Aurobindo Pharma Limited under an ANDA.
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FDA approval · 2015-04-13FDA 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 · 2015-03-24FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for LAMICTAL XR (lamotrigine) filed by GlaxoSmithKline LLC.
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FDA approval · 2015-03-24FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) from GlaxoSmithKline LLC. The action indicates an approved change to …
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FDA approval · 2015-03-18FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for ziprasidone hydrochloride by Apotex Corp., approving the generic product under the ANDA.
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FDA approval · 2015-03-17FDA Approved: RISPERIDONE — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approved a supplemental application for risperidone by Ajanta Pharma USA Inc., expanding its regulatory clearance for additional indicat…
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FDA approval · 2015-03-13FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental NDA for Depakote Sprinkles (divalproex sodium) from AbbVie, updating labeling and/or indications for the Spr…
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FDA approval · 2015-03-03FDA Approved: LITHIUM CARBONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA has approved Glenmark Pharmaceuticals Inc., USA's supplemental application for Lithium carbonate (generic) under ANDA 079139. The approv…
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FDA approval · 2015-02-20FDA Approved: OLANZAPINE — Original Application (Macleods Pharmaceuticals Limited)
FDA approved Macleods Pharmaceuticals Limited's generic olanzapine (oral) under ANDA203044. It covers indications for schizophrenia and bipo…
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FDA approval · 2015-02-18FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)
The FDA approved a supplemental application for carbamazepine filed by Apotex Corp., indicating an approved modification to the generic prod…
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FDA approval · 2015-02-18FDA Approved: LAMOTRIGINE — Supplemental Application (Advagen Pharma Limited)
FDA approved a supplemental application for lamotrigine by Advagen Pharma Limited (ANDA 078625).
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FDA approval · 2015-02-04FDA Approved: ZIPRASIDONE — Supplemental Application (Chartwell RX, LLC)
The FDA approved a supplemental application for Ziprasidone from Chartwell RX, LLC, enabling a generic version of the antipsychotic to be ma…
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FDA approval · 2015-01-20FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Carbamazepine from Torrent Pharmaceuticals Limited, indicating an approved action on an existing…
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FDA approval · 2015-01-20FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for EPITOL (carbamazepine) from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2015-01-20FDA Approved: OLANZAPINE — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved a supplemental application for the generic olanzapine, manufactured by Dr. Reddy's Laboratories Inc.
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FDA approval · 2015-01-17FDA Approved: OLANZAPINE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved Torrent Pharmaceuticals Limited's supplemental application for olanzapine (generic) under the ANDA pathway. This represents a s…