Schizophrenia

• FDA approval · 2010-09-03
  FDA Approved: SAPHRIS — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for SAPHRIS (asenapine maleate) by Allergan, Inc.

• FDA approval · 2010-08-30
  FDA Approved: RISPERDAL CONSTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Risperdal Consta (risperidone) submitted by Janssen Pharmaceuticals, Inc., resulting in a la…

• FDA approval · 2010-08-30
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal M-TAB (risperidone) from Janssen Pharmaceuticals, expanding or updating its formulatio…

• FDA approval · 2010-08-24
  FDA Approved: FANAPT — Supplemental Application (Vanda Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Fanapt (iloperidone) submitted by Vanda Pharmaceuticals.

• FDA approval · 2010-08-06
  FDA Approved: RISPERIDONE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's generic risperidone (ANDA) for the same indications as the brand-label. The approval covers schizophrenia,…

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• FDA approval · 2010-08-06
  FDA Approved: RISPERIDONE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries, Inc.'s original ANDA for risperidone, providing a generic version of this antipsychotic.

• FDA approval · 2010-07-08
  FDA Approved: ZYPREXA RELPREVV — Supplemental Application (H2-Pharma LLC)

  FDA approved a supplemental application for ZYPREXA RELPREVV (olanzapine pamoate) submitted by H2-Pharma LLC.

• FDA approval · 2010-06-29
  FDA Approved: RISPERIDONE — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved Torrent Pharmaceuticals Limited's supplemental application for risperidone, updating the labeling for this generic product.

• FDA approval · 2010-05-27
  FDA Approved: ZYPREXA RELPREVV — Supplemental Application (H2-Pharma LLC)

  The FDA approved a supplemental application for ZYPREXA RELPREVV (olanzapine pamoate) submitted by H2-Pharma LLC.

• FDA approval · 2010-05-27
  FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2010-05-27
  FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ZYPREXA ZYDIS (olanzapine) submitted by Eli Lilly and Company.

• FDA approval · 2010-05-13
  FDA Approved: INVEGA SUSTENNA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for INVEGA SUSTENNA (paliperidone palmitate) by Janssen Pharmaceuticals, updating the labeling for t…

• FDA approval · 2010-04-30
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Clozapine by Mylan Pharmaceuticals, updating labeling for the generic antipsychotic.

• FDA approval · 2010-04-27
  FDA Approved: RISPERIDONE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for risperidone from ANI Pharmaceuticals, Inc., under an ANDA.

• FDA approval · 2010-04-27
  FDA Approved: ZYPREXA RELPREVV — Supplemental Application (H2-Pharma LLC)

  FDA approved a supplemental application for ZYPREXA RELPREVV (olanzapine pamoate) submitted by H2-Pharma LLC.

• FDA approval · 2010-04-15
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

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

• FDA approval · 2010-02-26
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for HALOPERIDOL DECANOATE from Mylan Institutional LLC under an ANDA, confirming approval of this ge…

• FDA approval · 2010-02-19
  FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals, LLC's supplemental application for risperidone (ANDA 078707). This action represents an approval r…

• FDA approval · 2010-01-29
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Haloperidol Decanoate by Hikma Pharmaceuticals USA Inc. (AP status: AP).

• FDA approval · 2010-01-27
  FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Zyprexa Intramuscular (olanzapine) submitted by Eli Lilly.

• FDA approval · 2010-01-27
  FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for ZYPREXA ZYDIS (olanzapine) submitted by Eli Lilly and Company.

• FDA approval · 2010-01-12
  FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for risperidone filed by Zydus Lifesciences Limited, granting approval for a generic version und…

• FDA approval · 2010-01-07
  FDA Approved: FLUPHENAZINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approves a supplemental application for Fluphenazine hydrochloride from PAI Holdings/PAI Pharma.

• FDA approval · 2009-12-15
  FDA Approved: RISPERIDONE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for risperidone from ANI Pharmaceuticals, Inc., resulting in a generic risperidone product being…

• FDA approval · 2009-12-11
  FDA Approved: ZYPREXA RELPREVV — Original Application (H2-Pharma LLC)

  FDA approved ZYPREXA RELPREVV (olanzapine pamoate) under an Original Application, providing a long-acting injectable option for schizophreni…