Schizophrenia

• FDA approval · 2008-06-26
  FDA Approved: CLOZARIL — Supplemental Application (HLS Therapeutics (USA), Inc.)

  The FDA approved a supplemental application for Clozaril (clozapine) submitted by HLS Therapeutics (USA), Inc.

• FDA approval · 2008-06-18
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Haloperidol decanoate from Hikma Pharmaceuticals USA Inc., resulting in an update to the product…

• 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 · 2008-05-29
  FDA Approved: PERPHENAZINE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for perphenazine submitted by Sandoz Inc.

• FDA approval · 2008-05-21
  FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for SEROQUEL XR (quetiapine) from AstraZeneca Pharmaceuticals LP.

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• FDA approval · 2008-05-16
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Geodon (ziprasidone mesylate) submitted by Viatris Specialty LLC.

• FDA approval · 2008-05-16
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for GEODON (ziprasidone) submitted by Viatris Specialty LLC.

• FDA approval · 2008-05-13
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Patriot Pharmaceuticals LLC)

  FDA approved a supplemental application for haloperidol decanoate from Patriot Pharmaceuticals LLC, resulting in labeling changes for this l…

• FDA approval · 2008-04-28
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Mylan Institutional LLC)

  FDA approves a supplemental application for HALOPERIDOL DECANOATE from Mylan Institutional LLC (a long-acting injectable antipsychotic).

• FDA approval · 2008-02-04
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Haloperidol Decanoate by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2007-12-31
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for haloperidol decanoate from Mylan Institutional LLC.

• 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…

• FDA approval · 2007-11-07
  FDA Approved: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for the generic combination product perphenazine and amitriptyline hydrochloride by Mylan Pharmaceut…

• FDA approval · 2007-10-02
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Geodon (ziprasidone mesylate) submitted by Viatris Specialty LLC.

• FDA approval · 2007-10-02
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA supplemental approval for Geodon (ziprasidone) by Viatris Specialty LLC.

• FDA approval · 2007-09-19
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Patriot Pharmaceuticals LLC)

  FDA approved a supplemental application for haloperidol decanoate (long-acting injectable antipsychotic) submitted by Patriot Pharmaceutical…

• FDA approval · 2007-07-06
  FDA Approved: ZYPREXA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for ZYPREXA (olanzapine) from Eli Lilly and Company.

• FDA approval · 2007-07-06
  FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)

  FDA Supplemental Application filed for ZYPREXA ZYDIS (olanzapine) by Eli Lilly and Company.

• FDA approval · 2007-05-24
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Geodon (ziprasidone mesylate) submitted by Viatris Specialty LLC.

• FDA approval · 2007-05-24
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC.

• FDA approval · 2007-05-17
  FDA Approved: SEROQUEL XR — Original Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved the original NDA for SEROQUEL XR (quetiapine) from AstraZeneca Pharmaceuticals LP, establishing the extended-release formul…

• FDA approval · 2007-05-04
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Patriot Pharmaceuticals LLC)

  FDA approved a supplemental application for HALOPERIDOL DECANOATE submitted by Patriot Pharmaceuticals LLC. HALOPERIDOL DECANOATE is a long-…

• FDA approval · 2007-04-12
  FDA Approved: RISPERDAL CONSTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal Consta (risperidone) from Janssen Pharmaceuticals.

• FDA approval · 2007-03-09
  FDA Approved: RISPERDAL CONSTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal Consta (risperidone) from Janssen Pharmaceuticals, Inc., marking an addition or modifi…

• FDA approval · 2007-02-09
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for HALOPERIDOL DECANOATE from Mylan Institutional LLC under the ANDA process. The approval updates …