Schizophrenia

• 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 · 2025-09-03
  FDA Approved: ZIPRASIDONE MESYLATE — Original Application (STERISCIENCE SPECIALTIES PRIVATE LIMITED)

  FDA approved an original application for ziprasidone mesylate from SterisScience Specialties Private Limited, enabling a generic version of …

• FDA approval · 2025-09-02
  FDA Approved: RISPERIDONE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' generic risperidone through an Original Application for use in established indications.

• 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.

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• FDA approval · 2025-08-18
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for haloperidol decanoate from Mylan Institutional LLC, a long-acting injectable antipsychotic.

• FDA approval · 2025-08-12
  FDA Approved: LURASIDONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Lurasidone hydrochloride submitted by Sun Pharmaceutical Industries, Inc. The action relates…

• FDA approval · 2025-07-30
  FDA Approved: LOXAPINE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for LOXAPINE by Actavis Pharma, Inc.

• FDA approval · 2025-07-30
  FDA Approved: LOXAPINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for LOXAPINE (loxapine) from Actavis Pharma, Inc., under an ANDA submission.

• FDA approval · 2025-07-30
  FDA Approved: LOXAPINE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for LOXAPINE (loxapine) from Actavis Pharma, Inc., signaling an update to the drug's labeling un…

• FDA approval · 2025-07-30
  FDA Approved: LOXAPINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for LOXAPINE by Actavis Pharma, Inc. under ANDA072206, indicating an updated indication or label for…

• FDA approval · 2025-07-24
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for haloperidol decanoate from NorthStar RxLLC.

• FDA approval · 2025-07-23
  FDA Approved: LURASIDONE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' supplemental ANDA for Lurasidone hydrochloride, enabling a generic version to be marketed in the U.S. L…

• FDA approval · 2025-07-08
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for quetiapine fumarate from Aurobindo Pharma Limited to market the generic product for the same ind…

• FDA approval · 2025-07-01
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for HALOPERIDOL DECANOATE by Fresenius Kabi USA, LLC.

• FDA approval · 2025-07-01
  FDA Approved: LURASIDONE HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Lurasidone Hydrochloride from Macleods Pharmaceuticals Limited, authorizing the generic product.…

• FDA approval · 2025-06-24
  FDA Approved: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for a generic Perphenazine and Amitriptyline Hydrochloride product by Mylan Pharmaceuticals.

• FDA approval · 2025-06-20
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for Haloperidol Decanoate from Fresenius Kabi USA, LLC, indicating regulatory authorization for …

• 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 · 2025-06-13
  FDA Approved: CLOZARIL — Supplemental Application (HLS Therapeutics (USA), Inc.)

  The FDA notes a supplemental application for Clozaril (clozapine) submitted by HLS Therapeutics (USA), Inc., seeking a regulatory change to …

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

  The FDA approves a supplemental application for Clozapine submitted by Teva Pharmaceuticals USA, Inc., resulting in an approved supplemental…

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

  FDA approved a supplemental application for Clozapine from Accord Healthcare Inc., approving a change to the approved product.

• FDA approval · 2025-06-13
  FDA Approved: CLOZAPINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Clozapine submitted by Aurobindo Pharma Limited.

• FDA approval · 2025-06-13
  FDA Approved: VERSACLOZ — Supplemental Application (TruPharma LLC)

  The FDA approved a supplemental application for Versacloz (clozapine) submitted by TruPharma LLC.