Bipolar Disorder

• FDA approval · 2012-01-24
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for carbamazepine from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2012-01-03
  FDA Approved: RISPERIDONE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for risperidone from Torrent Pharmaceuticals Limited.

• FDA approval · 2012-01-03
  FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for risperidone from Zydus Lifesciences Limited, enabling changes to an already approved generic…

• FDA approval · 2011-12-06
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lithium carbonate from Hikma Pharmaceuticals USA Inc. The approval updates the product under…

• FDA approval · 2011-11-29
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL XR (lamotrigine) from GlaxoSmithKline, indicating an updated approval related to the ex…

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• FDA approval · 2011-11-29
  FDA Approved: RISPERIDONE — Original Application (Solco Healthcare US, LLC)

  The FDA approved the original application for a generic risperidone manufactured by Solco Healthcare US, LLC. The approval covers standard i…

• FDA approval · 2011-11-28
  FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for a generic risperidone product from Amneal Pharmaceuticals NY LLC under ANDA 078071.

• FDA approval · 2011-11-15
  FDA Approved: RISPERIDONE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for risperidone by Chartwell RX, LLC, related to the generic product's labeling.

• FDA approval · 2011-11-15
  FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approves Westminster Pharmaceuticals' supplemental application for risperidone (generic), updating its approved status under an ANDA.

• FDA approval · 2011-11-10
  FDA Approved: RISPERIDONE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic risperidone product from Aurobindo Pharma Limited.

• FDA approval · 2011-11-09
  FDA Approved: SEROQUEL — Supplemental Application (H2-Pharma, LLC)

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

• FDA approval · 2011-11-09
  FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA has approved a supplemental application for SEROQUEL XR (quetiapine) by AstraZeneca Pharmaceuticals LP. The approval pertains to mod…

• FDA approval · 2011-11-08
  FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application to approve a generic risperidone product from Amneal Pharmaceuticals LLC under ANDA 091384.

• FDA approval · 2011-11-04
  FDA Approved: RISPERIDONE — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved Jubilant Cadista's generic risperidone under an Original Application (ANDA 090839).

• FDA approval · 2011-10-30
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2011-10-30
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2011-10-25
  FDA Approved: OLANZAPINE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved the Original Application for olanzapine from Torrent Pharmaceuticals Limited, marking the introduction of a generic olanzapine …

• FDA approval · 2011-10-24
  FDA Approved: OLANZAPINE — Original Application (Sandoz Inc)

  FDA approved the Original Application for olanzapine from Sandoz Inc., making a generic olanzapine available (ANDA 201588).

• FDA approval · 2011-10-24
  FDA Approved: OLANZAPINE — Original Application (Dr. Reddy's Laboratories Ltd.)

  FDA approved an original generic application for olanzapine from Dr. Reddy's Laboratories Ltd.

• FDA approval · 2011-10-24
  FDA Approved: OLANZAPINE — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original ANDA for generic olanzapine (olanzapine tablets). The product is indicated for schizophrenia and bipola…

• FDA approval · 2011-10-24
  FDA Approved: OLANZAPINE — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's original application for a generic olanzapine product (ANDA076534), enabling market entry of…

• FDA approval · 2011-10-20
  FDA Approved: LITHOBID — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for LITHOBID (lithium carbonate) from ANI Pharmaceuticals, Inc.

• FDA approval · 2011-10-20
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for lithium carbonate submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2011-10-06
  FDA Approved: LAMOTRIGINE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved Unichem Pharmaceuticals (USA), Inc.'s original application for lamotrigine, making a generic version available for treatmen…

• FDA approval · 2011-09-29
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for the Lamotrigine Kit from OWP Pharmaceuticals, Inc., authorizing a supplemental marketing use…