Psychotic Disorders

• FDA approval · 2025-12-18
  FDA Approved: HALOPERIDOL — Original Application (Creekwood Pharmaceuticals LLC)

  FDA approved Creekwood Pharmaceuticals' generic haloperidol under an original ANDA (ANDA 218162).

• FDA approval · 2025-11-18
  FDA Approved: FLUPHENAZINE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' generic fluphenazine hydrochloride under an ANDA, expanding access to this antipsychotic used to treat …

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

  FDA approved a supplemental application for HALOPERIDOL submitted by Innogenix, Inc., marking an approved update to the product through a su…

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

  FDA approved a supplemental application for fluphenazine hydrochloride from Fresenius Kabi USA, LLC.

• FDA approval · 2024-10-04
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Piramal Critical Care Inc.)

  FDA approved a generic chlorpromazine hydrochloride product (Original Application) from Piramal Critical Care Inc.

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• EMA approval · 2024-07-12
  EMA Authorised: Invega (paliperidone) — Janssen-Cilag International NV

  The EMA authorised Invega (paliperidone) from Janssen-Cilag International NV for schizophrenia and related psychotic disorders. This marks i…

• FDA approval · 2024-03-13
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved an original ANDA for chlorpromazine hydrochloride from Zydus Pharmaceuticals USA Inc., making this generic antipsychotic availa…

• FDA approval · 2023-08-18
  FDA Approved: FLUPHENAZINE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved the Original Application for Fluphenazine hydrochloride from Aurobindo Pharma Limited, granting approval of a generic antipsych…

• FDA approval · 2021-03-01
  FDA Approved: FLUPHENAZINE HYDROCHLORIDE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved the original application for fluphenazine hydrochloride as a generic product, submitted by ANI Pharmaceuticals, Inc.

• FDA approval · 2015-11-03
  FDA Approved: CHLORPROMAZINE HCI — Supplemental Application (Dr. Reddy's Laboratories Inc.,)

  FDA approved a supplemental application for chlorpromazine HCl from Dr. Reddy's Laboratories, authorizing the generic version to be marketed…

• FDA approval · 2011-09-13
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for chlorpromazine hydrochloride from Upsher-Smith Laboratories, signaling an approved update to the…

• FDA approval · 2011-09-02
  FDA Approved: HALOPERIDOL — Original Application (Sagent Pharmaceuticals)

  FDA approved HALOPERIDOL lactate injectable as an Original Application by Sagent Pharmaceuticals. This adds a generic HALOPERIDOL lactate pr…

• FDA approval · 2010-12-06
  FDA Approved: HALOPERIDOL — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for haloperidol submitted by Zydus Lifesciences Limited.

• FDA approval · 2010-12-03
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for chlorpromazine hydrochloride from Upsher-Smith Laboratories, indicating an updated regulatory ac…

• FDA approval · 2009-08-24
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for chlorpromazine hydrochloride from Upsher-Smith Laboratories, a generic antipsychotic.

• FDA approval · 2009-07-21
  FDA Approved: FLUPHENAZINE HYDROCHLORIDE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for Fluphenazine hydrochloride from Fresenius Kabi USA, LLC, confirming/expanding its generic pr…

• FDA approval · 2008-11-25
  FDA Approved: TRIFLUOPERAZINE HYDROCHLORIDE — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for trifluoperazine hydrochloride from Sandoz Inc., confirming an additional approval for this gener…

• FDA approval · 2008-11-25
  FDA Approved: HALOPERIDOL — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for HALOPERIDOL (generic) from PAI Holdings, LLC dba PAI Pharma under ANDA073037.

• FDA approval · 2008-05-29
  FDA Approved: HALOPERIDOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for HALOPERIDOL LACTATE from Hikma Pharmaceuticals USA Inc., under the ANDA framework.

• FDA approval · 2008-05-15
  FDA Approved: COMPRO — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for COMPRO (prochlorperazine) submitted by Padagis US LLC. This action updates the product’s approva…

• FDA approval · 2007-11-29
  FDA Approved: HALOPERIDOL — Original Application (Zydus Lifesciences Limited)

  FDA approved HALOPERIDOL from Zydus Lifesciences Limited under an Original Application (ANDA), providing a generic version of haloperidol. T…