Bipolar Disorder

• FDA approval · 2009-02-24
  FDA Approved: RISPERIDONE — Original Application (Amici Pharma, Inc.)

  FDA approves the original application for a risperidone generic from Amici Pharma, Inc.

• FDA approval · 2009-02-19
  FDA Approved: LAMOTRIGINE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved an original application for a generic lamotrigine product manufactured by Glenmark Pharmaceuticals Inc., expanding generic …

• FDA approval · 2009-02-03
  FDA Approved: LITHIUM CARBONATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's original ANDA for lithium carbonate, making the generic mood stabilizer available for use in bipolar disorder.

• FDA approval · 2009-01-30
  FDA Approved: RISPERIDONE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approves ANI Pharmaceuticals' original application for risperidone, adding a generic version of the antipsychotic.

• FDA approval · 2009-01-27
  FDA Approved: LAMOTRIGINE — Original Application (Advagen Pharma Limited)

  FDA approved Advagen Pharma Limited's Original Application for lamotrigine, enabling a generic lamotrigine product.

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• FDA approval · 2009-01-27
  FDA Approved: LAMOTRIGINE KIT — Original Application (OWP Pharmaceuticals, Inc.)

  FDA approves Lamotrigine Kit under an original ANDA application by OWP Pharmaceuticals, Inc. for generic lamotrigine products.

• FDA approval · 2009-01-27
  FDA Approved: LAMOTRIGINE — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved Jubilant Cadista Pharmaceuticals Inc.'s original ANDA for lamotrigine, establishing a generic lamotrigine product.

• FDA approval · 2009-01-27
  FDA Approved: DIVALPROEX SODIUM — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved an original application for a generic divalproex sodium product from Zydus Pharmaceuticals USA Inc.

• FDA approval · 2009-01-27
  FDA Approved: LAMOTRIGINE — Original Application (Aurobindo Pharma Limited)

  The FDA approved an original ANDA for Lamotrigine from Aurobindo Pharma Limited, providing a generic lamotrigine product. The product is ind…

• FDA approval · 2009-01-27
  FDA Approved: LAMOTRIGINE — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories' generic lamotrigine under Original Application (ANDA). The approval covers the generic product for la…

• FDA approval · 2009-01-27
  FDA Approved: LAMOTRIGINE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original ANDA for lamotrigine from Zydus Pharmaceuticals USA Inc., establishing a generic version of the anti-epileptic and…

• FDA approval · 2009-01-27
  FDA Approved: LAMOTRIGINE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's original ANDA for lamotrigine, enabling a generic lamotrigine product to reach the market.

• FDA approval · 2009-01-23
  FDA Approved: DIVALPROEX SODIUM — Original Application (NorthStar Rx LLC)

  The FDA approved NorthStar Rx LLC's original application for divalproex sodium (generic).

• FDA approval · 2009-01-22
  FDA Approved: LAMOTRIGINE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original ANDA for lamotrigine, a generic version manufactured by Zydus Pharmaceuticals USA Inc.

• FDA approval · 2009-01-22
  FDA Approved: LAMOTRIGINE — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approved the Original Application for Lamotrigine as a generic product from Dr. Reddy's Laboratories Limited.

• FDA approval · 2009-01-12
  FDA Approved: LITHIUM CARBONATE LITHIUM CARBONATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' generic lithium carbonate under an original ANDA. The product is used as a mood stabilizer for bipolar…

• FDA approval · 2008-11-25
  FDA Approved: DIVALPROEX SODIUM — Original Application (Bionpharma Inc.)

  FDA approved Bionpharma's original application for divalproex sodium, making a generic version available for epilepsy, bipolar disorder, and…

• FDA approval · 2008-11-25
  FDA Approved: HALOPERIDOL — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for HALOPERIDOL (generic) from PAI Holdings, LLC dba PAI Pharma under ANDA073037.

• FDA approval · 2008-11-19
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for chlorpromazine hydrochloride (Upsher-Smith Laboratories, LLC).

• FDA approval · 2008-11-19
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for chlorpromazine hydrochloride from Upsher-Smith Laboratories, approving changes to the approved d…

• FDA approval · 2008-11-19
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for chlorpromazine hydrochloride from Upsher-Smith Laboratories, LLC. This action updates the ap…

• FDA approval · 2008-10-30
  FDA Approved: RISPERIDONE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's original application for risperidone, providing a generic version of the antipsychotic.

• FDA approval · 2008-10-16
  FDA Approved: RISPERIDONE — Original Application (Zydus Lifesciences Limited)

  FDA approved an original abbreviated new drug application for risperidone by Zydus Lifesciences Limited, enabling the sale of a generic risp…

• FDA approval · 2008-09-08
  FDA Approved: LOXAPINE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application from Actavis Pharma, Inc. for LOXAPINE (loxapine), establishing a generic loxapine product.

• FDA approval · 2008-08-14
  FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Zyprexa Intramuscular (olanzapine), adding an intramuscular formulation to the product. This…