Bipolar Disorder

• FDA approval · 2008-08-14
  FDA Approved: RISPERIDONE — Supplemental Application (Janssen Pharmaceutical, Inc.)

  FDA approved a supplemental application for risperidone from Janssen Pharmaceuticals, updating the drug's labeling.

• FDA approval · 2008-08-14
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2008-08-14
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approves a supplemental application for Geodon (ziprasidone mesylate) filed by Viatris Specialty LLC.

• FDA approval · 2008-07-29
  FDA Approved: DIVALPROEX SODIUM — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic divalproex sodium (Original Application), enabling a generic version of the reference product.

• FDA approval · 2008-07-29
  FDA Approved: DIVALPROEX SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' divalproex sodium as an original ANDA (generic) application.

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• FDA approval · 2008-07-29
  FDA Approved: DIVALPROEX SODIUM — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approved a generic version of divalproex sodium from Dr. Reddy's Laboratories Limited under an Original Application (ANDA).

• FDA approval · 2008-07-28
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)

  FDA approved Apotex Corp.'s supplemental application for carbamazepine (generic), signifying approval of a supplemental ANDA for this produc…

• FDA approval · 2008-05-21
  FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for SEROQUEL XR (quetiapine) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2008-05-16
  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 · 2008-05-16
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2008-04-28
  FDA Approved: LITHIUM — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  The FDA approved a supplemental application for Lithium from PAI Holdings dba PAI Pharma, updating an already-approved product under the AND…

• FDA approval · 2008-04-21
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for carbamazepine from Sun Pharmaceutical Industries, Inc., updating the approved generic product un…

• FDA approval · 2008-04-17
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for carbamazepine submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2008-03-24
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA has approved a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie.

• FDA approval · 2008-03-24
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie. The approval covers changes to Depakote ER'…

• FDA approval · 2008-02-11
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

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

• FDA approval · 2008-02-11
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for a generic Carbamazepine product from Torrent Pharmaceuticals Limited (ANDA 077272).

• FDA approval · 2008-01-11
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for carbamazepine submitted by Chartwell RX, LLC for an existing generic product.

• FDA approval · 2007-12-26
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

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

• FDA approval · 2007-12-26
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

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

• FDA approval · 2007-12-19
  FDA Approved: EQUETRO — Supplemental Application (Validus Pharmaceuticals LLC)

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

• FDA approval · 2007-12-17
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved Torrent Pharmaceuticals Limited's supplemental application for Carbamazepine, a generic antiepileptic. The action updates t…

• FDA approval · 2007-12-11
  FDA Approved: TEGRETOL XR — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Tegretol XR (carbamazepine) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2007-12-11
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2007-10-31
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lithium carbonate from Hikma Pharmaceuticals USA Inc., signaling a regulatory change to the …