Autism Spectrum Disorder

• FDA approval · 2024-05-28
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved a supplemental application for aripiprazole submitted by Alembic Pharmaceuticals Inc., authorizing a modification to the pr…

• FDA approval · 2024-03-15
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for aripiprazole submitted by Chartwell RX, LLC, indicating regulatory approval of a supplement rela…

• FDA approval · 2024-03-05
  FDA Approved: RISPERIDONE — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved a supplemental application for risperidone filed by Solco Healthcare US, LLC.

• FDA approval · 2024-03-05
  FDA Approved: RISPERIDONE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for risperidone from Chartwell RX, LLC, authorizing the generic product under the approved label.

• FDA approval · 2023-12-05
  FDA Approved: RISPERIDONE — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva Pharmaceuticals' generic risperidone as an original application (ANDA214068).

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• FDA approval · 2023-11-01
  FDA Approved: ARIPIPRAZOLE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' generic oral aripiprazole under an original ANDA.

• FDA approval · 2023-09-18
  FDA Approved: RISPERIDONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved a supplemental application for risperidone by Jubilant Cadista Pharmaceuticals Inc., updating/expanding its approval for risper…

• FDA approval · 2023-08-08
  FDA Approved: RISPERIDONE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for risperidone from Aurobindo Pharma Limited, authorizing a generic risperidone product under ANDA …

• FDA approval · 2023-06-15
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for aripiprazole from Quallent Pharmaceuticals Health LLC.

• FDA approval · 2023-04-28
  FDA Approved: UZEDY — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved UZEDY (risperidone) through an original application from Teva Pharmaceuticals USA, Inc. for the treatment of schizophrenia, bip…

• FDA approval · 2023-01-31
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (VistaPharm, LLC)

  FDA approved a supplemental application for aripiprazole filed by VistaPharm, LLC, marking approval of a supplemental submission for this ge…

• FDA approval · 2022-10-27
  FDA Approved: ARIPIPRAZOLE — Original Application (Advagen Pharma Ltd)

  FDA approves Advagen Pharma Ltd's original application for a generic aripiprazole product.

• FDA approval · 2022-10-25
  FDA Approved: RISPERIDONE — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved a supplemental application for risperidone submitted by Solco Healthcare US, LLC.

• FDA approval · 2022-10-25
  FDA Approved: ARIPIPRAZOLE — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's original application for a generic aripiprazole product. Aripiprazole is used to treat schizophrenia, b…

• FDA approval · 2022-09-20
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Dr.Reddys Laboratories Inc)

  FDA approved a supplemental application for ARIPIPRAZOLE by Dr. Reddy's Laboratories Inc. under the ANDA, authorizing a modification to the …

• FDA approval · 2022-05-27
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for aripiprazole filed by Amneal Pharmaceuticals LLC (generic aripiprazole).

• FDA approval · 2021-08-31
  FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves a supplemental application for risperidone by Amneal Pharmaceuticals LLC. This action represents a supplemental approval under …

• FDA approval · 2021-02-12
  FDA Approved: RISPERIDONE — Supplemental Application (Janssen Pharmaceutical, Inc.)

  The FDA approved Janssen's supplemental application for risperidone, resulting in changes to its labeling/indications.

• FDA approval · 2020-11-17
  FDA Approved: RISPERIDONE — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved Solco Healthcare US, LLC's supplemental application to market a generic risperidone product.

• FDA approval · 2020-10-28
  FDA Approved: RISPERIDONE — Supplemental Application (Natco Pharma USA LLC)

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

• FDA approval · 2020-10-19
  FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for risperidone by Amneal Pharmaceuticals LLC.

• FDA approval · 2020-02-20
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Dr.Reddys Laboratories Inc)

  The FDA approved a supplemental application for aripiprazole from Dr. Reddy's Laboratories Inc., supporting regulatory action for the generi…

• FDA approval · 2020-02-05
  FDA Approved: RISPERDAL — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Risperdal (risperidone) from Janssen Pharmaceuticals, Inc. The action updates the product la…

• FDA approval · 2020-02-05
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  The FDA approves a supplemental application for ARIPIPRAZOLE (Aripiprazole) from Lannett Company, expanding approval of a generic antipsycho…

• FDA approval · 2020-02-05
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Inc)

  FDA approved Dr. Reddy's supplemental application to manufacture and market aripiprazole orally disintegrating tablets as a generic product.