Schizophrenia

• 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 · 2009-12-04
  FDA Approved: ZYPREXA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for ZYPREXA (olanzapine) filed by Eli Lilly and Company, expanding the regulatory scope of the produ…

• FDA approval · 2009-12-02
  FDA Approved: RISPERIDONE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approves a supplemental application for a generic risperidone version manufactured by Torrent Pharmaceuticals Limited.

• FDA approval · 2009-11-20
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2009-11-12
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for GEODON (ziprasidone) from Viatris Specialty LLC, updating the product’s labeling.

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• 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 · 2009-09-04
  FDA Approved: RISPERIDONE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original application for risperidone, a generic antipsychotic, authorizing its manufacturing and mar…

• FDA approval · 2009-08-31
  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. The action concerns the ZYPREXA Z…

• 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 · 2009-08-24
  FDA Approved: RISPERIDONE — Supplemental Application (Amici Pharma, Inc.)

  FDA approved a supplemental application for risperidone by Amici Pharma, Inc., signaling a labeling update or additional indication for the …

• FDA approval · 2009-08-18
  FDA Approved: PERPHENAZINE — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for PERPHENAZINE submitted by Endo USA, Inc., resulting in an updated labeling for the product.

• FDA approval · 2009-08-18
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA granted a supplemental approval for chlorpromazine hydrochloride from Upsher-Smith Laboratories, LLC.

• FDA approval · 2009-08-13
  FDA Approved: SAPHRIS — Original Application (Allergan, Inc.)

  The FDA approved SAPHRIS (asenapine maleate) from Allergan in an original application for the treatment of schizophrenia and for the acute t…

• FDA approval · 2009-07-31
  FDA Approved: INVEGA SUSTENNA — Original Application (Janssen Pharmaceuticals, Inc.)

  This FDA entry records the original NDA approval of Invega Sustenna (paliperidone palmitate) by Janssen Pharmaceuticals for the treatment of…

• FDA approval · 2009-07-31
  FDA Approved: INVEGA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for INVEGA (paliperidone) submitted by Janssen Pharmaceuticals, Inc.

• FDA approval · 2009-07-22
  FDA Approved: FLUPHENAZINE DECANOATE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved Fresenius Kabi USA's supplemental application for fluphenazine decanoate, a long-acting injectable antipsychotic, indicatin…

• 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 · 2009-07-19
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal M-TAB (risperidone) from Janssen Pharmaceuticals. The notice lists the submission stat…

• FDA approval · 2009-07-19
  FDA Approved: RISPERDAL CONSTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal Consta, the long-acting injectable form of risperidone, submitted by Janssen Pharmaceu…

• FDA approval · 2009-07-19
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2009-07-19
  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 · 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 · 2009-06-17
  FDA Approved: RISPERIDONE — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's original ANDA for risperidone, authorizing a generic version of the antipsychotic.

• FDA approval · 2009-06-04
  FDA Approved: LOXAPINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approves a supplemental application for LOXAPINE (loxapine) by Actavis Pharma, Inc., resulting in an updated marketing authorization for…

• FDA approval · 2009-06-04
  FDA Approved: LOXAPINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for LOXAPINE (loxapine) by Actavis Pharma, Inc., resulting in changes to its labeling. The approval …