Schizophrenia

• FDA approval · 2023-06-05
  FDA Approved: QUETIAPINE — Supplemental Application (Accord Healthcare Inc.)

  The FDA approved Accord Healthcare Inc.'s supplemental application for quetiapine (ANDA 202152), granting approval of a generic quetiapine p…

• FDA approval · 2023-05-30
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approves a supplemental application for quetiapine fumarate submitted by Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2023-05-23
  FDA Approved: HALOPERIDOL DECANOATE — Original Application (NorthStar RxLLC)

  The FDA approved NorthStar RxLLC's HALOPERIDOL DECANOATE as an original ANDA for a long-acting injectable antipsychotic indicated for schizo…

• FDA approval · 2023-05-19
  FDA Approved: CLOZARIL — Supplemental Application (HLS Therapeutics (USA), Inc.)

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

• FDA approval · 2023-05-11
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for quetiapine fumarate submitted by BluePoint Laboratories. This action approves a modification to …

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2023-05-11
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for quetiapine fumarate filed by Sun Pharmaceutical Industries.

• FDA approval · 2023-05-11
  FDA Approved: QUETIAPINE EXTENDED RELEASE — Supplemental Application (ACI Healthcare USA, Inc.)

  FDA approves a supplemental application for a generic Quetiapine Extended Release product from ACI Healthcare USA, expanding access to the e…

• FDA approval · 2023-05-11
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for quetiapine fumarate from Aurobindo Pharma Limited, enabling generic production under an Abbrevia…

• FDA approval · 2023-05-11
  FDA Approved: QUETIAPINE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA granted a supplemental approval for Quetiapine (generic) from Ascend Laboratories, LLC, approving an additional application for this…

• FDA approval · 2023-05-10
  FDA Approved: REXULTI — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  The FDA approved a supplemental application for Rexulti (brexpiprazole) submitted by Otsuka America Pharmaceutical, Inc., resulting in chang…

• FDA approval · 2023-04-28
  FDA Approved: UZEDY — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved UZEDY (risperidone) through an original application from Teva Pharmaceuticals USA, Inc. for the treatment of schizophrenia, bip…

• FDA approval · 2023-04-26
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Haloperidol Decanoate by Hikma Pharmaceuticals USA Inc., authorizing changes under an existi…

• FDA approval · 2023-04-26
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Clozapine filed by Mylan Pharmaceuticals Inc., enabling continued generic availability under…

• FDA approval · 2023-04-26
  FDA Approved: CLOZAPINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Clozapine from Teva Pharmaceuticals USA, Inc., updating its labeling to reflect new information.

• FDA approval · 2023-04-20
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Ingenus Pharmaceuticals, LLC)

  FDA approved a supplemental application for quetiapine fumarate from Ingenus Pharmaceuticals, LLC, marking an additional approval/modificati…

• FDA approval · 2023-04-19
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for quetiapine fumarate from Aurobindo Pharma Limited, authorizing a generic version under an ANDA.

• FDA approval · 2023-04-19
  FDA Approved: QUETIAPINE — Supplemental Application (Solco Healthcare U.S., LLC)

  FDA approved a supplemental application for quetiapine from Solco Healthcare U.S., LLC to authorize a generic version of the drug for the U.…

• FDA approval · 2023-03-30
  FDA Approved: FLUPHENAZINE DECANOATE — Original Application (Sagent Pharmaceuticals)

  The FDA approved a generic fluphenazine decanoate long-acting injectable from Sagent Pharmaceuticals under an Original Application, enabling…

• FDA approval · 2023-03-22
  FDA Approved: OLANZAPINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for a generic olanzapine product. The approval enables marketing of the olanzapine…

• FDA approval · 2023-03-10
  FDA Approved: LURASIDONE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original ANDA for lurasidone hydrochloride, a generic antipsychotic indicated for schizophrenia and …

• FDA approval · 2023-03-01
  FDA Approved: PALIPERIDONE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application to bring a generic paliperidone product to market.

• FDA approval · 2023-02-24
  FDA Approved: OLANZAPINE — Original Application (Modavar Pharmaceuticals LLC)

  The FDA approved Modavar Pharmaceuticals LLC's original application for olanzapine, a generic antipsychotic. It is approved for the treatmen…

• FDA approval · 2023-02-10
  FDA Approved: OLANZAPINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for olanzapine from Dr. Reddy's Laboratories Limited (ANDA 076534), authorizing a generic olanzapine…

• FDA approval · 2023-02-03
  FDA Approved: BREXPIPRAZOLE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original application for brexpiprazole (brexpiprazole), authorizing a generic version of the antipsych…

• FDA approval · 2023-01-31
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (VistaPharm, LLC)

  FDA approved a supplemental application for aripiprazole filed by VistaPharm, LLC, marking approval of a supplemental submission for this ge…