Irritability Associated with Autistic Disorder

• FDA approval · 2025-09-02
  FDA Approved: RISPERIDONE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approval of a generic risperidone original application by Amneal Pharmaceuticals LLC.

• FDA approval · 2023-11-01
  FDA Approved: UZEDY — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for UZEDY (risperidone) from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2023-07-17
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for aripiprazole from Ascend Laboratories, allowing a generic version to be marketed.

• FDA approval · 2023-06-12
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for ARIPIPRAZOLE submitted by Unichem Pharmaceuticals (USA), Inc., enabling the generic product to b…

• FDA approval · 2021-02-01
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Inc)

  FDA approves Dr. Reddy's Laboratories' supplemental application to add a generic aripiprazole orally disintegrating tablet.

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• FDA approval · 2020-02-05
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Apotex Corp.)

  FDA approved Apotex Corp.’s supplemental application for aripiprazole (generic aripiprazole), authorizing the sale of a generic version of t…

• FDA approval · 2015-08-14
  FDA Approved: ARIPIPRAZOLE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal's original ANDA for aripiprazole (ARIPIPRAZOLE), enabling the marketing of a generic version of this antipsychotic.

• FDA approval · 2013-08-30
  FDA Approved: RISPERIDONE — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for risperidone submitted by Par Health USA, LLC (ANDA 077494).

• FDA approval · 2013-03-22
  FDA Approved: RISPERIDONE — Supplemental Application (Natco Pharma USA LLC)

  FDA approved a supplemental application for risperidone from Natco Pharma USA LLC under an ANDA.

• FDA approval · 2011-11-08
  FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application to approve a generic risperidone product from Amneal Pharmaceuticals LLC under ANDA 091384.