Schizophrenia

• 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 · 2017-02-23
  FDA Approved: PERPHENAZINE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental labeling application for PERPHENAZINE from Sandoz Inc, resulting in updates to the product's labeling.

• 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 · 2016-03-29
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

  The FDA approved a supplemental application for LATUDA (lurasidone hydrochloride) submitted by Sumitomo Pharma America, Inc., resulting in a…

• FDA label_change · 2015-07-29
  FDA Approved: ABILIFY MAINTENA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental application for ABILIFY MAINTENA (aripiprazole long-acting injectable) from Otsuka America Pharmaceutical, Inc.,…

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• 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 · 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 · 2014-09-30
  FDA Approved: CLOZARIL — Supplemental Application (HLS Therapeutics (USA), Inc.)

  FDA approved a supplemental labeling application for CLOZARIL (clozapine) submitted by HLS Therapeutics (USA), Inc.

• 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 · 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 · 2013-05-24
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Patriot Pharmaceuticals LLC)

  FDA approved a supplemental application for haloperidol decanoate, resulting in changes to the labeling of this long-acting antipsychotic.

• FDA label_change · 2013-03-22
  FDA Approved: CLOZARIL — Supplemental Application (HLS Therapeutics (USA), Inc.)

  The FDA approved a supplemental application for Clozaril (clozapine) to update its labeling. The change is related to the product's labeling…

• 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.

• 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 · 2012-03-12
  FDA Approved: RISPERDAL CONSTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for RISPERDAL CONSTA (risperidone) submitted by Janssen, likely resulting in labeling changes.

• 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 · 2010-12-03
  FDA Approved: FLUPHENAZINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for fluphenazine hydrochloride filed by PAI Holdings (PAI Pharma) to update the labeling.

• 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 · 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 · 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 · 2007-04-27
  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.