Schizophrenia

• FDA approval · 2016-06-30
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for HALOPERIDOL DECANOATE from Fresenius Kabi USA, LLC (ANDA074893). The approval denotes regulatory…

• FDA approval · 2016-06-17
  FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for SEROQUEL XR (quetiapine) from AstraZeneca Pharmaceuticals LP. This action modifies the product l…

• FDA approval · 2016-05-18
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Patriot Pharmaceuticals LLC)

  FDA approved a supplemental application for HALOPERIDOL DECANOATE by Patriot Pharmaceuticals LLC, updating the product's approval status.

• FDA approval · 2016-05-17
  FDA Approved: QUETIAPINE FUMARATE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for a generic version of quetiapine fumarate by Macleods Pharmaceuticals Limited.

• FDA approval · 2016-05-06
  FDA Approved: CLOZARIL — Supplemental Application (HLS Therapeutics (USA), Inc.)

  FDA approved a supplemental application for Clozaril (clozapine) submitted by HLS Therapeutics (USA), Inc., indicating approved changes to t…

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• FDA approval · 2016-04-25
  FDA Approved: PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE (Mylan Pharmaceuticals Inc.). This action updates t…

• FDA approval · 2016-04-19
  FDA Approved: THIORIDAZINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approves a supplemental application for thioridazine hydrochloride (generic) submitted by Chartwell RX, LLC.

• FDA approval · 2016-04-19
  FDA Approved: THIORIDAZINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for thioridazine hydrochloride, with Chartwell RX, LLC as the sponsor.

• FDA approval · 2016-04-19
  FDA Approved: THIORIDAZINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for thioridazine hydrochloride by Chartwell RX, LLC under ANDA 088134.

• FDA approval · 2016-04-19
  FDA Approved: THIORIDAZINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for thioridazine hydrochloride (Chartwell RX, LLC). This is a routine regulatory action on an approv…

• FDA approval · 2016-03-29
  FDA Approved: FANAPT — Supplemental Application (Vanda Pharmaceuticals Inc.)

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

• FDA approval · 2016-03-24
  FDA Approved: ARISTADA — Supplemental Application (Alkermes, Inc.)

  FDA approved a supplemental application for ARISTADA (aripiprazole lauroxil) from Alkermes, Inc.

• FDA approval · 2016-03-08
  FDA Approved: QUETIAPINE FUMARATE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Quetiapine Fumarate as a generic tablet under Original Application (ANDA 202674) for Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2016-03-01
  FDA Approved: RISPERIDONE — Supplemental Application (Janssen Pharmaceutical, Inc.)

  FDA approved a supplemental application for risperidone submitted by Janssen Pharmaceutical, Inc.

• FDA approval · 2016-03-01
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Risperdal M-Tab (risperidone) from Janssen Pharmaceuticals.

• FDA approval · 2016-03-01
  FDA Approved: RISPERDAL — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal (risperidone) by Janssen Pharmaceuticals, Inc.

• FDA approval · 2016-03-01
  FDA Approved: INVEGA SUSTENNA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for INVEGA SUSTENNA (paliperidone palmitate) filed by Janssen Pharmaceuticals.

• FDA approval · 2016-03-01
  FDA Approved: INVEGA HAFYERA — Supplemental Application (Janssen Pharmaceuticals, Inc)

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

• FDA approval · 2016-02-18
  FDA Approved: VERSACLOZ — Supplemental Application (TruPharma LLC)

  The FDA approved a supplemental application for Versacloz (clozapine) submitted by TruPharma LLC.

• FDA approval · 2016-01-27
  FDA Approved: OLANZAPINE — Original Application (Upsher-Smith Laboratories, LLC)

  Approval of a generic olanzapine product under an Original Application (ANDA) by Upsher-Smith Laboratories, LLC.

• FDA approval · 2016-01-22
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved Mylan Pharmaceuticals' supplemental application for clozapine (generic), enabling a generic version under ANDA201824.

• FDA approval · 2016-01-04
  FDA Approved: QUETIAPINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for a generic quetiapine product from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2015-12-23
  FDA Approved: ZYPREXA RELPREVV — Supplemental Application (H2-Pharma LLC)

  The FDA approved a supplemental application for ZYPREXA RELPREVV (olanzapine pamoate) from H2-Pharma LLC. This action approves the supplemen…

• FDA approval · 2015-12-17
  FDA Approved: PERPHENAZINE — Original Application (Wilshire Pharmaceuticals, Inc.)

  The FDA approved a generic version of perphenazine under ANDA205973 from Wilshire Pharmaceuticals, Inc.

• FDA approval · 2015-11-27
  FDA Approved: OLANZAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for olanzapine from Macleods Pharmaceuticals Limited.