Schizophrenia

• FDA approval · 2010-12-06
  FDA Approved: TRIFLUOPERAZINE HYDROCHLORIDE — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for trifluoperazine hydrochloride from Sandoz Inc., a generic antipsychotic, resulting in updated la…

• FDA approval · 2010-12-06
  FDA Approved: TRIFLUOPERAZINE HYDROCHLORIDE — Supplemental Application (Sandoz Inc.)

  The FDA approved a supplemental application for trifluoperazine hydrochloride by Sandoz Inc. under an ANDA. This action updates the already-…

• FDA approval · 2010-12-03
  FDA Approved: TRIFLUOPERAZINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for trifluoperazine hydrochloride from Mylan Pharmaceuticals Inc., confirming approval of a gene…

• FDA approval · 2010-12-03
  FDA Approved: FLUPHENAZINE DECANOATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Fluphenazine decanoate by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2010-12-03
  FDA Approved: LOXAPINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for LOXAPINE submitted by Actavis Pharma, Inc. (ANDA072062).

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2010-12-03
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for chlorpromazine hydrochloride from Upsher-Smith Laboratories, LLC.

• FDA approval · 2010-12-03
  FDA Approved: FLUPHENAZINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  The FDA approved a supplemental application for fluphenazine hydrochloride (generic) submitted by PAI Holdings, LLC dba PAI Pharma under AND…

• FDA approval · 2010-12-03
  FDA Approved: FLUPHENAZINE DECANOATE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Fluphenazine Decanoate from Fresenius Kabi USA, LLC, confirming approval of an additional produc…

• FDA approval · 2010-12-03
  FDA Approved: FLUPHENAZINE DECANOATE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for Fluphenazine decanoate from Mylan Institutional LLC under an ANDA, allowing continued marketing …

• FDA approval · 2010-12-03
  FDA Approved: FLUPHENAZINE HYDROCHLORIDE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Fluphenazine hydrochloride by Fresenius Kabi USA, LLC, signaling a regulatory action on this pro…

• FDA approval · 2010-12-03
  FDA Approved: THIORIDAZINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approves a supplemental application for thioridazine hydrochloride submitted by Mylan Pharmaceuticals Inc., indicating a new or revised …

• FDA approval · 2010-12-03
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for chlorpromazine hydrochloride from Upsher-Smith Laboratories, indicating an updated regulatory ac…

• FDA approval · 2010-12-03
  FDA Approved: FLUPHENAZINE HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)

  FDA approves a supplemental application for Fluphenazine hydrochloride from Lannett Company, Inc.

• FDA approval · 2010-12-01
  FDA Approved: RISPERDAL — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for risperidone (RISPERDAL) from Janssen Pharmaceuticals, Inc., resulting in changes to its labe…

• FDA approval · 2010-12-01
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC. The approval covers the supplemental su…

• FDA approval · 2010-12-01
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2010-12-01
  FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2010-12-01
  FDA Approved: SAPHRIS — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Saphris (asenapine) by Allergan to update its labeling, potentially reflecting an expanded or cl…

• FDA approval · 2010-12-01
  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 · 2010-12-01
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved Janssen's supplemental application for Risperdal M-TAB (risperidone), a supplemental filing related to the M-TAB formulatio…

• FDA approval · 2010-12-01
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Patriot Pharmaceuticals LLC)

  FDA approved a supplemental application for haloperidol decanoate (long-acting antipsychotic) submitted by Patriot Pharmaceuticals LLC.

• FDA approval · 2010-12-01
  FDA Approved: CLOZARIL — Supplemental Application (HLS Therapeutics (USA), Inc.)

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

• FDA approval · 2010-12-01
  FDA Approved: FANAPT — Supplemental Application (Vanda Pharmaceuticals Inc.)

  FDA approved a supplemental application for Fanapt (iloperidone) filed by Vanda Pharmaceuticals, indicating an expansion related to its appr…

• FDA approval · 2010-12-01
  FDA Approved: INVEGA SUSTENNA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INVEGA SUSTENNA (paliperidone palmitate) from Janssen Pharmaceuticals.

• FDA approval · 2010-10-28
  FDA Approved: LATUDA — Original Application (Sumitomo Pharma America, Inc.)

  The FDA approved Latuda (lurasidone hydrochloride) under NDA 200603 from Sumitomo Pharma America, marking the original approval of lurasidon…