Bipolar Disorder

• FDA label_change · 2026-03-20
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for carbamazepine from Torrent Pharmaceuticals Limited, resulting in labeling changes for the generi…

• 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 · 2025-10-23
  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 · 2025-10-10
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal ODT (lamotrigine) from GlaxoSmithKline, likely updating labeling to reflect the orally …

• 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: 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 · 2024-07-15
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Sun Pharmaceutical Industries, Inc. The action pertains to labeli…

• FDA label_change · 2023-08-25
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for the generic lithium carbonate from Glenmark Pharmaceuticals, likely to update the product’s …

• FDA label_change · 2023-05-19
  FDA Approved: LAMOTRIGINE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for lamotrigine submitted by Actavis Pharma, Inc. The action pertains to updating or amending th…

• 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 · 2022-10-13
  FDA Approved: LITHIUM — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  The FDA approved a supplemental application for Lithium from PAI Holdings (PAI Pharma) to an already approved drug, likely resulting in labe…

• FDA label_change · 2022-06-10
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lamotrigine from Zydus Pharmaceuticals USA Inc., signaling a labeling change or addition to …

• 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 · 2020-08-31
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA supplemental application approval for LAMICTAL ODT (lamotrigine) by GlaxoSmithKline, seeking changes to the product labeling.

• FDA label_change · 2020-08-31
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal XR (lamotrigine) submitted by GlaxoSmithKline LLC, resulting in changes to the product …

• FDA label_change · 2020-08-31
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Lamictal (lamotrigine) from GlaxoSmithKline, updating the product labeling.

• FDA label_change · 2020-07-06
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for divalproex sodium from Zydus Pharmaceuticals USA Inc. to update 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 · 2020-01-29
  FDA Approved: LAMOTRIGINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Lamotrigine filed by Amneal Pharmaceuticals of New York LLC, indicating changes to its label…

• 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 · 2019-09-25
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal ODT (lamotrigine) submitted by GlaxoSmithKline LLC, updating the product labeling.

• 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…