Schizophrenia

• FDA label_change · 2025-12-18
  FDA Approved: VRAYLAR — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for VRAYLAR (cariprazine) from Allergan, Inc.

• FDA label_change · 2025-10-30
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Patriot Pharmaceuticals LLC)

  FDA approved a supplemental application for haloperidol decanoate submitted by Patriot Pharmaceuticals LLC, resulting in a label update for …

• FDA label_change · 2025-10-23
  FDA Approved: OLANZAPINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for olanzapine from Aurobindo Pharma Limited. This action typically involves labeling changes for th…

• FDA label_change · 2025-01-22
  FDA Approved: CLOZARIL — Supplemental Application (HLS Therapeutics (USA), Inc.)

  The FDA approved a supplemental application for CLOZARIL (clozapine) submitted by HLS Therapeutics USA, Inc., resulting in an update to the …

• FDA label_change · 2025-01-22
  FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for ZYPREXA INTRAMUSCULAR (olanzapine) from Eli Lilly and Company, updating the labeling to include …

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• FDA label_change · 2025-01-22
  FDA Approved: FLUPHENAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  This document records Upsher-Smith's supplemental application for labeling changes to Fluphenazine hydrochloride.

• FDA label_change · 2025-01-22
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

  The FDA approved a supplemental application for Latuda (lurasidone hydrochloride) filed by Sumitomo Pharma America, Inc. This action updates…

• FDA label_change · 2025-01-22
  FDA Approved: HALOPERIDOL — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental labeling application for HALOPERIDOL from Zydus Lifesciences Limited, updating the existing product labeling…

• FDA label_change · 2025-01-22
  FDA Approved: TRIFLUOPERAZINE HYDROCHLORIDE — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for trifluoperazine hydrochloride from Sandoz Inc., indicating a label change to an existing product…

• FDA label_change · 2025-01-22
  FDA Approved: THIORIDAZINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for thioridazine hydrochloride from Chartwell RX, LLC, likely updating labeling for this generic ant…

• FDA label_change · 2023-04-26
  FDA Approved: VERSACLOZ — Supplemental Application (TruPharma LLC)

  FDA notes a supplemental application for Versacloz (clozapine) by TruPharma LLC, indicating a labeling change or amendment to the approved p…

• FDA label_change · 2023-03-27
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for haloperidol decanoate, updating the labeling for the product.

• FDA label_change · 2022-12-02
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved Janssen's supplemental application for Risperdal M-TAB (risperidone), updating labeling and introducing the M-TAB dosage form.

• FDA label_change · 2021-11-10
  FDA Approved: VERSACLOZ — Supplemental Application (TruPharma LLC)

  The FDA approved a supplemental application for VERSACLOZ (clozapine) submitted by TruPharma LLC.

• FDA label_change · 2021-07-19
  FDA Approved: ASENAPINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for asenapine from Alembic Pharmaceuticals Limited, resulting in updated labeling for the drug.

• FDA label_change · 2021-02-12
  FDA Approved: RISPERDAL CONSTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Risperdal Consta (risperidone) from Janssen Pharmaceuticals to update the product labeling, …

• FDA label_change · 2021-02-11
  FDA Approved: CLOZARIL — Supplemental Application (HLS Therapeutics (USA), Inc.)

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

• FDA label_change · 2020-03-27
  FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for SEROQUEL XR (quetiapine) from AstraZeneca, resulting in labeling updates for the drug.

• FDA label_change · 2020-02-05
  FDA Approved: SEROQUEL — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental application for SEROQUEL (quetiapine) submitted by H2-Pharma, LLC, affecting the product labeling. The action re…

• FDA label_change · 2019-12-04
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

  FDA approved a supplemental application for LATUDA (lurasidone hydrochloride) from Sumitomo Pharma America, Inc.

• FDA label_change · 2019-10-22
  FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ZYPREXA ZYDIS (olanzapine) submitted by Eli Lilly and Company, resulting in labeling changes…

• FDA label_change · 2019-06-18
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Haloperidol decanoate, updating the product label under the Hikma Pharmaceuticals USA Inc. filin…

• FDA label_change · 2019-01-25
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA supplemental application for Risperdal M-TAB (risperidone) by Janssen Pharmaceuticals, involving changes to the product label. This acti…

• FDA label_change · 2019-01-16
  FDA Approved: VERSACLOZ — Supplemental Application (TruPharma LLC)

  FDA approved a supplemental application for Versacloz (clozapine) by TruPharma LLC. The action updates the product labeling.

• 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.