Bipolar Disorder

• FDA approval · 2009-11-12
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for GEODON (ziprasidone) from Viatris Specialty LLC, updating the product’s labeling.

• FDA approval · 2009-11-04
  FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for EPITOL (carbamazepine) from Teva Pharmaceuticals USA, Inc. The document does not specify the cha…

• FDA approval · 2009-11-04
  FDA Approved: LAMOTRIGINE — Original Application (Aurobindo Pharma Limited)

  FDA approved a new generic lamotrigine product from Aurobindo Pharma Limited under an Original Application (ANDA).

• FDA approval · 2009-09-25
  FDA Approved: LITHIUM CARBONATE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' lithium carbonate as a generic, marking the Original Application under ANDA090702 for market authorizat…

• FDA approval · 2009-09-22
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for lamotrigine from Aurobindo Pharma Limited.

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• FDA approval · 2009-09-21
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approves a supplemental application for the Lamotrigine Kit from OWP Pharmaceuticals, Inc. under ANDA078947, confirming the continued av…

• FDA approval · 2009-09-21
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for lamotrigine filed by Dr. Reddy's Laboratories Limited.

• FDA approval · 2009-09-21
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  The FDA approved a supplemental application for Lamotrigine by Dr. Reddy's Laboratories Limited, updating an existing Lamotrigine product. T…

• FDA approval · 2009-09-04
  FDA Approved: RISPERIDONE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original application for risperidone, a generic antipsychotic, authorizing its manufacturing and mar…

• FDA approval · 2009-08-31
  FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for ZYPREXA ZYDIS (olanzapine) submitted by Eli Lilly and Company. The action concerns the ZYPREXA Z…

• FDA approval · 2009-08-24
  FDA Approved: RISPERIDONE — Supplemental Application (Amici Pharma, Inc.)

  FDA approved a supplemental application for risperidone by Amici Pharma, Inc., signaling a labeling update or additional indication for the …

• FDA approval · 2009-08-13
  FDA Approved: SAPHRIS — Original Application (Allergan, Inc.)

  The FDA approved SAPHRIS (asenapine maleate) from Allergan in an original application for the treatment of schizophrenia and for the acute t…

• FDA approval · 2009-08-04
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (BluePoint Laboratories)

  FDA has approved a supplemental application for divalproex sodium from BluePoint Laboratories.

• FDA approval · 2009-07-19
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal M-TAB (risperidone) from Janssen Pharmaceuticals. The notice lists the submission stat…

• FDA approval · 2009-07-19
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC.

• FDA approval · 2009-06-17
  FDA Approved: RISPERIDONE — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's original ANDA for risperidone, authorizing a generic version of the antipsychotic.

• FDA approval · 2009-05-29
  FDA Approved: LAMICTAL XR — Original Application (GlaxoSmithKline LLC)

  FDA approved Lamictal XR (lamotrigine) in an original application by GlaxoSmithKline LLC, establishing the extended-release formulation for …

• FDA approval · 2009-05-27
  FDA Approved: LOXAPINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for LOXAPINE (loxapine) from Actavis Pharma, Inc., under ANDA072205. This action represents an appro…

• FDA approval · 2009-05-08
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for LAMICTAL (lamotrigine) submitted by GlaxoSmithKline LLC.

• FDA approval · 2009-05-08
  FDA Approved: LAMICTAL ODT — Original Application (GlaxoSmithKline LLC)

  The FDA approved a new orally disintegrating tablet formulation of lamotrigine (Lamictal ODT). It was approved under GlaxoSmithKline's origi…

• FDA approval · 2009-04-30
  FDA Approved: RISPERIDONE — Original Application (Par Health USA, LLC)

  FDA approves Par Health USA, LLC's original application for a generic risperidone product, expanding access to the standard indications for …

• FDA approval · 2009-04-23
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for TEGRETOL (carbamazepine) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2009-04-23
  FDA Approved: TEGRETOL XR — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol XR (carbamazepine) submitted by Novartis Pharmaceuticals, indicating an approved modifi…

• FDA approval · 2009-03-23
  FDA Approved: RISPERIDONE — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved the original application for Risperidone from Jubilant Cadista Pharmaceuticals Inc., enabling generic risperidone to be markete…

• FDA approval · 2009-02-27
  FDA Approved: DIVALPROEX SODIUM — Original Application (BluePoint Laboratories)

  FDA approved the original application for divalproex sodium (generic) by BluePoint Laboratories.