Schizophrenia

• FDA approval · 2020-01-23
  FDA Approved: QUETIAPINE EXTENDED-RELEASE — Supplemental Application (AlignScience Pharma Inc.)

  FDA approved AlignScience Pharma's supplemental ANDA for a quetiapine extended-release product, making a generic version of quetiapine exten…

• FDA approval · 2020-01-17
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved Zydus Lifesciences Limited's original ANDA for chlorpromazine hydrochloride, a generic antipsychotic. The approval supports use…

• FDA approval · 2020-01-08
  FDA Approved: HALOPERIDOL — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith Laboratories' haloperidol as an original generic (ANDA) product. The approval covers its use as a generic antipsyc…

• FDA approval · 2019-12-26
  FDA Approved: ZIPRASIDONE MESYLATE — Original Application (Fosun Pharma USA Inc.)

  FDA approved the original application for ziprasidone mesylate (generic) to treat schizophrenia and bipolar I disorder.

• FDA approval · 2019-12-26
  FDA Approved: ARIPIPRAZOLE — Original Application (VistaPharm, LLC)

  FDA approved VistaPharm, LLC's original ANDA (212870) for a generic aripiprazole. This approval makes a generic version of aripiprazole avai…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2019-12-23
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Mylan Institutional LLC)

  FDA records a supplemental application approval for HALOPERIDOL DECANOATE from Mylan Institutional LLC under ANDA075440.

• FDA approval · 2019-12-22
  FDA Approved: RISPERIDONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved a supplemental application for risperidone by Jubilant Cadista Pharmaceuticals Inc. This approval pertains to changes to the ap…

• FDA approval · 2019-12-20
  FDA Approved: CAPLYTA — Original Application (Intra-Cellular Therapies, Inc)

  The FDA approved CAPLYTA (lumateperone) in its original application by Intra-Cellular Therapies for the treatment of schizophrenia.

• FDA approval · 2019-12-20
  FDA Approved: QUETIAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for quetiapine from Macleods Pharmaceuticals Limited. The action provides regulatory approval for th…

• FDA approval · 2019-12-20
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for quetiapine fumarate from Aurobindo Pharma Limited, allowing continued marketing of this generic …

• FDA approval · 2019-12-11
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc.'s supplemental application for quetiapine fumarate, a generic formulation under ANDA 090749.

• FDA approval · 2019-12-11
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for Quetiapine Fumarate (ANDA 090120).

• FDA approval · 2019-12-10
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for ARIPIPRAZOLE from Amneal Pharmaceuticals LLC (aripiprazole).

• FDA approval · 2019-11-29
  FDA Approved: ZIPRASIDONE — Supplemental Application (Dr. Reddy's Laboratories Limited)

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

• FDA approval · 2019-11-29
  FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for ziprasidone hydrochloride from BluePoint Laboratories, authorizing its generic product to be mar…

• FDA approval · 2019-11-22
  FDA Approved: QUETIAPINE — Supplemental Application (Accord Healthcare Inc.)

  FDA approves a supplemental application for Quetiapine by Accord Healthcare Inc., granting regulatory approval for a generic version of the …

• FDA approval · 2019-11-12
  FDA Approved: RISPERIDONE — Supplemental Application (Ajanta Pharma USA Inc.)

  The FDA approved Ajanta Pharma USA Inc.'s supplemental application for risperidone, authorizing a generic version of the antipsychotic.

• FDA approval · 2019-10-29
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Sagent Pharmaceuticals)

  The FDA approved a supplemental application for HALOPERIDOL DECANOATE submitted by Sagent Pharmaceuticals.

• FDA approval · 2019-10-22
  FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ZYPREXA Intramuscular (olanzapine) from Eli Lilly. The approval relates to a supplemental su…

• FDA approval · 2019-10-22
  FDA Approved: ZYPREXA — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ZYPREXA (olanzapine) submitted by Eli Lilly and Company, resulting in updated labeling to re…

• FDA approval · 2019-10-22
  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. This action supplements th…

• FDA approval · 2019-10-22
  FDA Approved: HALOPERIDOL DECANOATE — Original Application (BluePoint Laboratories)

  The FDA approved BluePoint Laboratories' haloperidol decanoate long-acting injectable under an original application for the treatment of sch…

• FDA approval · 2019-10-11
  FDA Approved: SECUADO — Original Application (Noven Therapeutics, LLC)

  FDA approved SECUADO (asenapine) from Noven Therapeutics in an original NDA (212268) for treatment of schizophrenia and acute manic/mixed ep…

• FDA approval · 2019-09-23
  FDA Approved: PALIPERIDONE — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's generic paliperidone, authorizing a new generic antipsychotic for schizophrenia. This represen…

• FDA approval · 2019-09-04
  FDA Approved: LURASIDONE HYDROCHLORIDE — Original Application (Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approves a generic version of lurasidone hydrochloride under an original ANDA filed by Heritage Pharma Labs Inc. d/b/a Avet Pharmaceutic…