Bipolar Disorder

• FDA label_change · 2018-12-20
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Lithium carbonate submitted by Hikma Pharmaceuticals USA Inc., resulting in changes to the produ…

• FDA label_change · 2018-07-23
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal (lamotrigine) from GlaxoSmithKline, resulting in changes to the product labeling.

• FDA label_change · 2018-03-20
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Tegretol (carbamazepine) filed by Novartis Pharmaceuticals Corporation, updating the labelin…

• FDA label_change · 2017-10-05
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a labeling supplement for Depakote Sprinkles (divalproex sodium) submitted by AbbVie.

• FDA label_change · 2017-10-05
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

  FDA approved AbbVie's supplemental application for Depakote (divalproex sodium), leading to changes to the product labeling.

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• FDA label_change · 2017-06-22
  FDA Approved: QUETIAPINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for quetiapine (generic), updating the drug's labeling under the approved ANDA.

• FDA label_change · 2017-02-23
  FDA Approved: RISPERDAL — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Risperdal (risperidone) from Janssen Pharmaceuticals, resulting in changes to the product la…

• FDA label_change · 2016-08-29
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA supplemental application for chlorpromazine hydrochloride filed by Upsher-Smith Laboratories, LLC, related to labeling changes.

• FDA label_change · 2016-06-17
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol (carbamazepine) to update the labeling language.

• FDA label_change · 2016-05-19
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (NorthStar Rx LLC)

  FDA supplemental application for divalproex sodium filed by NorthStar Rx LLC, likely involving labeling updates or other product changes. Th…

• FDA label_change · 2016-02-18
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie, resulting in a labeling update for the produ…

• FDA label_change · 2015-08-28
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol (carbamazepine) submitted by Novartis, resulting in labeling changes.

• FDA label_change · 2015-06-17
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Geodon (ziprasidone) filed by Viatris Specialty LLC, resulting in a labeling update.

• FDA label_change · 2015-05-18
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal (lamotrigine) submitted by GlaxoSmithKline; the action updates the product labeling.

• FDA label_change · 2015-05-11
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for DIVALPROEX SODIUM (Divalproex Sodium) from Zydus Pharmaceuticals USA Inc., resulting in labeling…

• FDA label_change · 2014-11-08
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Sun Pharmaceutical Industries to update the product labeling.

• FDA label_change · 2014-11-06
  FDA Approved: QUETIAPINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for quetiapine by Teva Pharmaceuticals USA, Inc., resulting in labeling updates for the product. The…

• FDA label_change · 2014-09-26
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for lamotrigine from Zydus Pharmaceuticals USA Inc.

• FDA label_change · 2014-06-20
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie, updating regulatory information for the …

• FDA label_change · 2014-05-21
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

  The FDA approved a supplemental application for LATUDA (lurasidone hydrochloride) from Sumitomo Pharma America, resulting in changes to the …

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

  FDA approved a supplemental application for Tegretol (carbamazepine) filed by Novartis, leading to changes to the product labeling.

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

  The FDA approved a supplemental application for LAMICTAL (lamotrigine) submitted by GlaxoSmithKline LLC. The supplemental approval resulted …

• FDA label_change · 2013-10-21
  FDA Approved: ZYPREXA — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ZYPREXA (olanzapine) from Eli Lilly and Company, resulting in labeling changes for the medic…

• FDA label_change · 2013-06-14
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote (divalproex sodium) submitted by AbbVie, resulting in labeling changes for the prod…

• FDA label_change · 2013-03-18
  FDA Approved: OLANZAPINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

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