Bipolar Disorder

• FDA label_change · 2013-03-06
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA label_change · 2012-04-26
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

  FDA approved a supplemental application for Latuda (lurasidone hydrochloride) filed by Sumitomo Pharma America, Inc., resulting in labeling …

• FDA label_change · 2012-02-28
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for lamotrigine by Zydus Pharmaceuticals USA Inc., resulting in updated labeling for the product.

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

  FDA approved a supplemental application for Lamictal ODT (lamotrigine) filed by GlaxoSmithKline, resulting in changes to the product labelin…

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

  FDA approved a supplemental application for Lamictal (lamotrigine) to update the product labeling.

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• FDA label_change · 2011-08-24
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA page documents a supplemental application for RISPERDAL M-TAB (risperidone) by Janssen Pharmaceuticals, typically filed to support l…

• FDA label_change · 2011-08-09
  FDA Approved: SAPHRIS — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for SAPHRIS (asenapine) submitted by Allergan to update the product labeling.

• FDA label_change · 2011-06-08
  FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)

  FDA records a supplemental application for risperidone by Zydus Lifesciences Limited; specifics of the label changes are not provided in the…

• FDA label_change · 2010-12-01
  FDA Approved: ABILIFY — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  The FDA approved a supplemental application for ABILIFY (aripiprazole) submitted by Otsuka America Pharmaceutical, Inc., resulting in change…

• FDA label_change · 2010-09-10
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Mylan Pharmaceuticals Inc., resulting in a labeling update.

• FDA label_change · 2010-05-14
  FDA Approved: LAMOTRIGINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for lamotrigine from Sun Pharmaceutical Industries, resulting in labeling changes for the drug.

• FDA label_change · 2009-12-02
  FDA Approved: SEROQUEL — Supplemental Application (H2-Pharma, LLC)

  The FDA approved a supplemental application for SEROQUEL (quetiapine) submitted by H2-Pharma, LLC, likely involving changes to the drug's la…

• FDA label_change · 2009-03-25
  FDA Approved: LAMOTRIGINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA label_change · 2008-08-11
  FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for SEROQUEL XR (quetiapine) submitted by AstraZeneca Pharmaceuticals LP. This approval results in l…

• FDA label_change · 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. The update concerns …

• FDA label_change · 2007-04-27
  FDA Approved: INVEGA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INVEGA (paliperidone) from Janssen Pharmaceuticals, Inc. The approval updates the drug's lab…

• FDA label_change · 2006-10-20
  FDA Approved: SEROQUEL — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental application for SEROQUEL (quetiapine) submitted by H2-Pharma, LLC, likely involving labeling changes.

• FDA label_change · 2006-10-13
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote (divalproex sodium) submitted by AbbVie Inc. This action relates to changes impleme…