Bipolar Disorder

• FDA approval · 2025-01-27
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Carbamazepine from Torrent Pharmaceuticals Limited under an ANDA.

• FDA approval · 2025-01-24
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for ARIPIPRAZOLE from Aurobindo Pharma Limited.

• FDA approval · 2025-01-24
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' supplemental application for aripiprazole (ARIPIPRAZOLE) under the ANDA pathway.

• FDA approval · 2025-01-24
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved a supplemental application for aripiprazole from Alembic Pharmaceuticals, enabling the marketing of a generic version. This…

• FDA approval · 2025-01-24
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Advagen Pharma Ltd)

  The FDA approved Advagen Pharma Ltd's supplemental application for aripiprazole, authorizing a generic ARIPIPRAZOLE product with the same in…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2025-01-24
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Apotex Corp.)

  FDA approves a supplemental application from Apotex Corp. for aripiprazole (ANDA204094), authorizing changes to the generic product's approv…

• FDA approval · 2025-01-24
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for aripiprazole oral from Camber Pharmaceuticals, resulting in approval of this generic product's l…

• FDA approval · 2025-01-24
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (VistaPharm, LLC)

  FDA approved a supplemental application for aripiprazole from VistaPharm, LLC, for a generic aripiprazole product.

• FDA approval · 2025-01-23
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie Inc.

• FDA approval · 2025-01-23
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for Lannett's generic aripiprazole, authorizing a generic formulation of the antipsychotic.

• FDA approval · 2025-01-23
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Inc)

  FDA approved a supplemental application to authorize a new orally disintegrating tablet formulation of aripiprazole from Dr. Reddy's Laborat…

• FDA approval · 2025-01-23
  FDA Approved: RISPERIDONE — Supplemental Application (Amici Pharma, Inc.)

  FDA approved a supplemental application for risperidone from Amici Pharma, Inc., updating the drug's labeling and/or indications. This actio…

• FDA approval · 2025-01-23
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Advagen Pharma Ltd)

  FDA approved Advagen Pharma Ltd's supplemental application for aripiprazole (ARIPIPRAZOLE) under ANDA216351.

• FDA approval · 2025-01-22
  FDA Approved: HALOPERIDOL — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Haloperidol lactate from Fresenius Kabi USA, LLC.

• 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 …

• FDA approval · 2025-01-22
  FDA Approved: RISPERIDONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for risperidone from Sun Pharmaceutical Industries, Inc., indicating an update to labeling or indica…

• 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 approval · 2025-01-22
  FDA Approved: SAPHRIS — Supplemental Application (Allergan, Inc.)

  The FDA approved Allergan's supplemental application for SAPHRIS (asenapine), resulting in changes to the product labeling.

• FDA approval · 2025-01-22
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC.

• FDA approval · 2025-01-22
  FDA Approved: RYKINDO EXTENDED-RELEASE MICROSPHERES — Supplemental Application (Shandong Luye Pharmaceutical Co., Ltd.)

  The FDA approved a supplemental application for RYKINDO Extended-Release Microspheres (risperidone) from Shandong Luye Pharmaceutical Co., L…

• FDA approval · 2025-01-22
  FDA Approved: HALOPERIDOL — Supplemental Application (AiPing Pharmaceutical, Inc)

  FDA approved AiPing Pharmaceutical's supplemental application for haloperidol, a generic antipsychotic.

• 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 approval · 2025-01-22
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal M-Tab (risperidone) from Janssen Pharmaceuticals, Inc., updating the product under a s…

• FDA approval · 2025-01-22
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approves a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC.

• FDA approval · 2025-01-22
  FDA Approved: HALOPERIDOL — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for HALOPERIDOL submitted by Lannett Company, Inc., authorizing changes to the product's approva…