Bipolar Disorder

• FDA approval · 2010-02-23
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for Lamotrigine from Dr. Reddy's Laboratories Limited.

• FDA approval · 2010-02-23
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for lamotrigine filed by Zydus Pharmaceuticals USA Inc., authorizing changes to the approved pro…

• FDA approval · 2010-02-23
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental application for carbamazepine (generic).

• FDA approval · 2010-02-19
  FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals, LLC's supplemental application for risperidone (ANDA 078707). This action represents an approval r…

• FDA approval · 2010-02-17
  FDA Approved: VALPROATE SODIUM — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved the original ANDA for valproate sodium, a generic anticonvulsant.

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• FDA approval · 2010-01-27
  FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Zyprexa Intramuscular (olanzapine) submitted by Eli Lilly.

• FDA approval · 2010-01-27
  FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2010-01-27
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a Supplemental Application for carbamazepine by Sun Pharmaceutical Industries, Inc. under an ANDA, marking an approved change t…

• FDA approval · 2010-01-21
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lamotrigine Kit submitted by OWP Pharmaceuticals, Inc.

• FDA approval · 2010-01-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for divalproex sodium submitted by Upsher-Smith Laboratories, LLC.

• FDA approval · 2010-01-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for divalproex sodium. The approval covers the submitted supplemental chang…

• FDA approval · 2010-01-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approves a supplemental application for divalproex sodium filed by Bionpharma Inc., resulting in an approved update under the ANDA proce…

• FDA approval · 2010-01-12
  FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for risperidone filed by Zydus Lifesciences Limited, granting approval for a generic version und…

• FDA approval · 2010-01-12
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2010-01-07
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

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

• FDA approval · 2010-01-06
  FDA Approved: VALPROIC ACID — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for valproic acid submitted by ANI Pharmaceuticals, Inc.

• FDA approval · 2010-01-06
  FDA Approved: VALPROIC ACID — Supplemental Application (Xttrium Laboratories Inc.)

  FDA approved a supplemental application for valproic acid from Xttrium Laboratories Inc., granting approval of a generic product.

• FDA approval · 2009-12-15
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Carbamazepine (generic) submitted by Chartwell RX, LLC.

• FDA approval · 2009-12-15
  FDA Approved: RISPERIDONE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for risperidone from ANI Pharmaceuticals, Inc., resulting in a generic risperidone product being…

• FDA approval · 2009-12-09
  FDA Approved: HALOPERIDOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for HALOPERIDOL LACTATE from Hikma Pharmaceuticals USA Inc., authorizing modifications under the AND…

• FDA approval · 2009-12-04
  FDA Approved: ZYPREXA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for ZYPREXA (olanzapine) filed by Eli Lilly and Company, expanding the regulatory scope of the produ…

• FDA approval · 2009-12-02
  FDA Approved: RISPERIDONE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approves a supplemental application for a generic risperidone version manufactured by Torrent Pharmaceuticals Limited.

• FDA approval · 2009-11-25
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Carbamazepine from Apotex Corp.

• FDA approval · 2009-11-20
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2009-11-18
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Carbamazepine by Torrent Pharmaceuticals Limited to update labeling.