Schizoaffective Disorder

• FDA approval · 2025-09-04
  FDA Approved: PALIPERIDONE — Original Application (Eskayef Pharmaceuticals Limited)

  FDA approved Eskayef Pharmaceuticals Limited's original application for paliperidone (generic paliperidone). The approval makes a generic ve…

• FDA approval · 2025-09-03
  FDA Approved: PALIPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal's supplemental application for a generic paliperidone product, expanding access to treatment for schizophrenia and schiz…

• FDA approval · 2025-06-13
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for a generic Clozapine product from Mylan Pharmaceuticals (ANDA201824). This action expands acc…

• FDA approval · 2025-06-13
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application from Mylan Pharmaceuticals Inc. to market a generic clozapine product (Clozapine) through an ANDA.

• FDA approval · 2025-03-27
  FDA Approved: PALIPERIDONE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for paliperidone by Ajanta Pharma USA Inc., supporting a generic version of the drug. This action re…

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• 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: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for CLOZAPINE from Mylan Pharmaceuticals Inc. The action relates to a modification of the generi…

• FDA approval · 2024-09-26
  FDA Approved: PALIPERIDONE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved a generic version of paliperidone through an Original Application (ANDA) for Alembic Pharmaceuticals Limited.

• FDA approval · 2024-07-08
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Clozapine submitted by Mylan Pharmaceuticals Inc. under the ANDA process.

• FDA approval · 2024-06-26
  FDA Approved: PALIPERIDONE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original application for a generic paliperidone product.

• FDA approval · 2024-05-29
  FDA Approved: OLANZAPINE — Supplemental Application (Sandoz Inc)

  FDA approved Sandoz Inc.'s supplemental application for olanzapine (ANDA201588). This action updates the approval for the generic product, p…

• FDA approval · 2024-03-21
  FDA Approved: PALIPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal's supplemental application for Paliperidone, enabling the marketing of a generic paliperidone product. This is an admini…

• FDA approval · 2023-09-21
  FDA Approved: PALIPERIDONE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for paliperidone filed by NorthStar RxLLC under ANDA205618.

• FDA approval · 2023-09-05
  FDA Approved: PALIPERIDONE — Supplemental Application (Tris Pharma Inc)

  FDA granted a supplemental approval for a generic paliperidone product from Tris Pharma Inc (ANDA 212807).

• FDA approval · 2023-08-23
  FDA Approved: PALIPERIDONE — Original Application (Camber Pharmaceuticals, Inc)

  FDA approved Camber Pharmaceuticals' generic paliperidone through original application, enabling a new generic option for this antipsychotic…

• FDA approval · 2023-04-26
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Clozapine filed by Mylan Pharmaceuticals Inc., enabling continued generic availability under…

• FDA approval · 2023-03-01
  FDA Approved: PALIPERIDONE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application to bring a generic paliperidone product to market.

• FDA approval · 2022-03-24
  FDA Approved: INVEGA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INVEGA (paliperidone) from Janssen Pharmaceuticals, Inc. This action approves changes descri…

• FDA approval · 2021-11-10
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Clozapine from Mylan Pharmaceuticals Inc., expanding its approved labeling and indications.

• FDA approval · 2021-11-10
  FDA Approved: CLOZAPINE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s Supplemental Application for CLOZAPINE, a generic version of clozapine under ANDA 202873. The approval…

• FDA approval · 2021-11-10
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approves Mylan's supplemental application for Clozapine, allowing a generic version of Clozapine to be marketed.

• FDA approval · 2021-11-01
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic quetiapine fumarate product from Aurobindo Pharma Limited, enabling its use as a g…

• FDA approval · 2021-07-29
  FDA Approved: CLOZAPINE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for clozapine from Accord Healthcare Inc. (generic clozapine). The approval pertains to a supplement…

• FDA approval · 2021-07-29
  FDA Approved: VERSACLOZ — Supplemental Application (TruPharma LLC)

  The FDA approved a supplemental application for Versacloz, a brand of clozapine, submitted by TruPharma LLC.

• FDA approval · 2021-02-18
  FDA Approved: CLOZAPINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Clozapine filed by Teva Pharmaceuticals USA, Inc. The approval indicates an update to the Cl…