Bipolar Disorder

• FDA approval · 2007-10-05
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lithium carbonate from Hikma Pharmaceuticals USA Inc., finalizing an additional regulatory a…

• FDA approval · 2007-10-02
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2007-10-02
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA supplemental approval for Geodon (ziprasidone) by Viatris Specialty LLC.

• FDA approval · 2007-09-28
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for lithium carbonate filed by Hikma Pharmaceuticals USA Inc., potentially updating the drug's l…

• FDA approval · 2007-08-16
  FDA Approved: TEGRETOL XR — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

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• FDA approval · 2007-08-16
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol (carbamazepine) filed by Novartis Pharmaceuticals Corporation; the approval updates the…

• FDA approval · 2007-07-06
  FDA Approved: ZYPREXA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for ZYPREXA (olanzapine) from Eli Lilly and Company.

• FDA approval · 2007-07-06
  FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)

  FDA Supplemental Application filed for ZYPREXA ZYDIS (olanzapine) by Eli Lilly and Company.

• FDA approval · 2007-05-24
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2007-05-24
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2006-12-17
  FDA Approved: VALPROIC ACID — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for valproic acid submitted by Bionpharma Inc.

• FDA approval · 2006-12-15
  FDA Approved: VALPROIC ACID — Supplemental Application (Xttrium Laboratories Inc.)

  The FDA approved a supplemental application for valproic acid from Xttrium Laboratories Inc., updating the approved ANDA.

• FDA approval · 2006-12-09
  FDA Approved: EQUETRO — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for EQUETRO (carbamazepine) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2006-11-29
  FDA Approved: ZYPREXA — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ZYPREXA (olanzapine) submitted by Eli Lilly and Company.

• FDA approval · 2006-11-29
  FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental NDA to add an intramuscular formulation of ZYPREXA (olanzapine) from Eli Lilly and Company.

• FDA approval · 2006-10-20
  FDA Approved: RISPERDAL CONSTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for RISPERDAL CONSTA (risperidone) from Janssen Pharmaceuticals, Inc.

• FDA approval · 2006-10-13
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie. The action updates labeling to reflect the a…

• FDA approval · 2006-10-06
  FDA Approved: RISPERIDONE — Supplemental Application (Janssen Pharmaceutical, Inc.)

  The FDA has approved a supplemental application for Risperidone submitted by Janssen Pharmaceutical, Inc.

• FDA approval · 2006-10-01
  FDA Approved: LITHOBID — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Lithobid (lithium carbonate) submitted by ANI Pharmaceuticals, Inc. This action confirms app…

• FDA approval · 2006-09-25
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL (lamotrigine) from GlaxoSmithKline LLC, indicating an update to the product label/inten…

• FDA approval · 2006-09-25
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Lamictal (lamotrigine) from GlaxoSmithKline LLC, resulting in updated labeling to reflect ex…

• FDA approval · 2006-09-20
  FDA Approved: SEROQUEL — Supplemental Application (H2-Pharma, LLC)

  The FDA approved a supplemental application for SEROQUEL (quetiapine) filed by H2-Pharma, LLC.

• FDA approval · 2006-08-25
  FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ZYPREXA ZYDIS (olanzapine) from Eli Lilly and Company, expanding the labeling for the Zydis …

• FDA approval · 2006-08-22
  FDA Approved: VALPROIC ACID — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for valproic acid from ANI Pharmaceuticals, indicating an approved change related to its product…