Schizophrenia

• FDA approval · 2014-06-05
  FDA Approved: RISPERDAL CONSTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved Janssen's supplemental application for RISPERDAL CONSTA, a long-acting injectable antipsychotic (paliperidone palmitate).

• FDA approval · 2014-05-30
  FDA Approved: ABILIFY MAINTENA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  The FDA approved a supplemental application for ABILIFY MAINTENA (aripiprazole long-acting injectable) submitted by Otsuka America Pharmaceu…

• FDA approval · 2014-05-15
  FDA Approved: OLANZAPINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for a generic olanzapine manufactured by Aurobindo Pharma Limited.

• FDA approval · 2014-04-29
  FDA Approved: INVEGA SUSTENNA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INVEGA SUSTENNA (paliperidone palmitate) by Janssen Pharmaceuticals, expanding regulatory ap…

• FDA approval · 2014-04-28
  FDA Approved: RISPERDAL — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal (risperidone) from Janssen Pharmaceuticals, Inc. The approval updates the drug's label…

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• FDA approval · 2014-04-28
  FDA Approved: RISPERDAL CONSTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for RISPERDAL CONSTA (risperidone) from Janssen Pharmaceuticals, Inc.

• FDA approval · 2014-04-22
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for quetiapine fumarate submitted by BluePoint Laboratories. This action grants updated regulatory a…

• FDA approval · 2014-03-28
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2014-03-25
  FDA Approved: VERSACLOZ — Supplemental Application (TruPharma LLC)

  FDA approved a supplemental application for VERSACLOZ (clozapine) from TruPharma LLC, updating the labeling per the supplemental filing.

• FDA approval · 2014-02-28
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

  FDA approved a supplemental application for LATUDA (lurasidone hydrochloride) submitted by Sumitomo Pharma America, Inc., resulting in an ap…

• FDA approval · 2014-02-18
  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 · 2013-12-19
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Patriot Pharmaceuticals LLC)

  The FDA approved a supplemental application for HALOPERIDOL DECANOATE from Patriot Pharmaceuticals LLC.

• FDA approval · 2013-12-17
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Geodon (ziprasidone) from Viatris Specialty LLC, indicating a regulatory action to modify or upd…

• FDA approval · 2013-12-05
  FDA Approved: VERSACLOZ — Supplemental Application (TruPharma LLC)

  The FDA approved a supplemental application for Versacloz (clozapine) submitted by TruPharma LLC. This action may involve updates to the pro…

• FDA approval · 2013-11-07
  FDA Approved: OLANZAPINE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  The FDA approved a supplemental application for OLANZAPINE from Jubilant Cadista Pharmaceuticals Inc. This is a routine regulatory action up…

• FDA approval · 2013-10-22
  FDA Approved: RISPERDAL CONSTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for RISPERDAL CONSTA (risperidone) from Janssen Pharmaceuticals.

• FDA approval · 2013-10-17
  FDA Approved: FLUPHENAZINE DECANOATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for fluphenazine decanoate from Hikma Pharmaceuticals USA, indicating an approved modification t…

• FDA approval · 2013-10-10
  FDA Approved: RISPERDAL CONSTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal Consta (risperidone) submitted by Janssen Pharmaceuticals, Inc. The action approves ch…

• FDA approval · 2013-09-19
  FDA Approved: ZIPRASIDONE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for ziprasidone filed by Dr. Reddy's Laboratories Limited.

• FDA approval · 2013-09-18
  FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for ziprasidone hydrochloride from Apotex Corp., confirming a generic version of the antipsychotic. …

• FDA approval · 2013-08-30
  FDA Approved: RISPERIDONE — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for risperidone submitted by Par Health USA, LLC (ANDA 077494).

• FDA approval · 2013-08-26
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

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

• FDA approval · 2013-08-26
  FDA Approved: INVEGA SUSTENNA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Invega Sustenna (paliperidone palmitate) filed by Janssen Pharmaceuticals, Inc. The approval…

• FDA approval · 2013-08-22
  FDA Approved: VERSACLOZ — Supplemental Application (TruPharma LLC)

  The FDA granted approval of a supplemental application for Versacloz (clozapine) submitted by TruPharma LLC.

• FDA approval · 2013-08-13
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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