Tourette Syndrome

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

  FDA approved a supplemental application for Haloperidol lactate from Fresenius Kabi USA, LLC.

• 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: HALOPERIDOL — Supplemental Application (AiPing Pharmaceutical, Inc)

  FDA approved AiPing Pharmaceutical's supplemental application for haloperidol, a generic antipsychotic.

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

  The FDA approved a supplemental application for HALOPERIDOL submitted by Lannett Company, Inc., authorizing changes to the product's approva…

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• FDA approval · 2025-01-16
  FDA Approved: HALOPERIDOL LACTATE — Supplemental Application (Mylan Institutional LLC)

  FDA granted a supplemental approval for HALOPERIDOL LACTATE to Mylan Institutional LLC, issuing a supplemental application for this generic …

• FDA approval · 2025-01-13
  FDA Approved: HALOPERIDOL — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for HALOPERIDOL LACTATE, a generic injectable form of haloperidol from Fresenius Kabi USA, LLC.

• FDA approval · 2024-04-11
  FDA Approved: HALOPERIDOL — Original Application (Lifestar Pharma LLC)

  FDA approved a generic haloperidol product from Lifestar Pharma LLC under an Original Application (ANDA 216918).

• FDA approval · 2022-11-18
  FDA Approved: HALOPERIDOL — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approves the original application for HALOPERIDOL, a generic product manufactured by Novadoz Pharmaceuticals LLC.

• FDA approval · 2020-01-08
  FDA Approved: HALOPERIDOL — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith Laboratories' haloperidol as an original generic (ANDA) product. The approval covers its use as a generic antipsyc…

• FDA approval · 2019-07-01
  FDA Approved: HALOPERIDOL — Original Application (Fresenius Kabi USA, LLC)

  FDA approved the original application for haloperidol lactate (HALOPERIDOL LACTATE) as a generic injectable from Fresenius Kabi USA, LLC.

• FDA approval · 2018-06-08
  FDA Approved: HALOPERIDOL — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for HALOPERIDOL LACTATE from Fresenius Kabi USA, LLC, authorizing changes to the marketed halope…

• FDA approval · 2017-02-23
  FDA Approved: HALOPERIDOL — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  The FDA approved a supplemental application for haloperidol from PAI Holdings (PAI Pharma) under ANDA073037, marking an additional approval …

• FDA approval · 2017-02-23
  FDA Approved: HALOPERIDOL — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for HALOPERIDOL from Lannett Company, Inc., under an Abbreviated New Drug Application (ANDA). Th…

• 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 · 2009-12-09
  FDA Approved: HALOPERIDOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for HALOPERIDOL LACTATE from Hikma Pharmaceuticals USA Inc., authorizing modifications under the AND…

• FDA approval · 2009-09-14
  FDA Approved: HALOPERIDOL LACTATE — Original Application (Mylan Institutional LLC)

  FDA approved the original application for HALOPERIDOL LACTATE from Mylan Institutional LLC, authorizing a generic injectable form of haloper…

• FDA approval · 2009-07-16
  FDA Approved: HALOPERIDOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for HALOPERIDOL by Mylan Pharmaceuticals Inc.

• 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 · 2008-10-30
  FDA Approved: HALOPERIDOL — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for haloperidol lactate from Fresenius Kabi USA, LLC, validating the generic product HALOPERIDOL LAC…

• 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 · 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…