Bipolar Disorder

• FDA approval · 2014-04-22
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for quetiapine fumarate submitted by BluePoint Laboratories. This action grants updated regulatory a…

• FDA approval · 2014-03-28
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2014-03-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Sun Pharmaceutical Industries.

• FDA approval · 2014-03-18
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for DIVALPROEX SODIUM submitted by Bionpharma Inc.

• FDA approval · 2014-03-18
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s supplemental application for carbamazepine, a generic anticonvulsant. This action updates the approval statu…

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• FDA approval · 2014-03-10
  FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for EPITOL (carbamazepine) from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2014-02-19
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved Torrent Pharmaceuticals Limited's supplemental application for carbamazepine, a generic anticonvulsant.

• FDA approval · 2014-02-19
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for carbamazepine from Torrent Pharmaceuticals Limited, indicating updated authorization for the…

• FDA approval · 2014-02-19
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for divalproex sodium from Unichem Pharmaceuticals (USA), Inc., indicating an approved change or add…

• FDA approval · 2014-02-11
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for divalproex sodium from Zydus Pharmaceuticals USA Inc.

• FDA approval · 2014-02-05
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for divalproex sodium submitted by NorthStar Rx LLC.

• FDA approval · 2014-01-16
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol (carbamazepine) filed by Novartis Pharmaceuticals Corporation. The action pertains to c…

• FDA approval · 2014-01-16
  FDA Approved: TEGRETOL XR — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2013-12-23
  FDA Approved: LAMOTRIGINE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's generic lamotrigine through an Original Application (ANDA). Lamotrigine is used to treat epil…

• FDA approval · 2013-12-20
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2013-12-20
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal ODT (lamotrigine) from GlaxoSmithKline LLC.

• FDA approval · 2013-12-20
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  FDA approves a supplemental application for Lamictal XR (lamotrigine) submitted by GlaxoSmithKline LLC.

• FDA approval · 2013-12-17
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Geodon (ziprasidone) from Viatris Specialty LLC, indicating a regulatory action to modify or upd…

• FDA approval · 2013-11-08
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2013-11-08
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approves a supplemental application for Tegretol (carbamazepine) submitted by Novartis Pharmaceuticals Corporation, resulting in an upda…

• FDA approval · 2013-11-07
  FDA Approved: OLANZAPINE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  The FDA approved a supplemental application for OLANZAPINE from Jubilant Cadista Pharmaceuticals Inc. This is a routine regulatory action up…

• FDA approval · 2013-10-17
  FDA Approved: LAMOTRIGINE — Original Application (Actavis Pharma, Inc.)

  FDA approved a generic lamotrigine product from Actavis Pharma under an Original Application (ANDA 200672).

• FDA approval · 2013-09-19
  FDA Approved: ZIPRASIDONE — Supplemental Application (Dr. Reddy's Laboratories Limited)

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

• FDA approval · 2013-09-18
  FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for ziprasidone hydrochloride from Apotex Corp., confirming a generic version of the antipsychotic. …

• FDA approval · 2013-08-30
  FDA Approved: RISPERIDONE — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for risperidone submitted by Par Health USA, LLC (ANDA 077494).