Bipolar Disorder

• FDA approval · 2017-02-23
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for chlorpromazine hydrochloride (Upsher-Smith Laboratories), updating an existing product's lab…

• FDA approval · 2017-02-23
  FDA Approved: HALOPERIDOL — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for HALOPERIDOL from Lannett Company, Inc., under an Abbreviated New Drug Application (ANDA). Th…

• FDA approval · 2017-02-23
  FDA Approved: VRAYLAR — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for VRAYLAR (cariprazine) submitted by Allergan, Inc.

• FDA approval · 2017-02-23
  FDA Approved: CHLORPROMAZINE HCI — Supplemental Application (Dr. Reddy's Laboratories Inc.,)

  FDA approved a supplemental application for Chlorpromazine HCl by Dr. Reddy's Laboratories Inc., granting approval for a generic version of …

• FDA approval · 2017-02-23
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Apotex Corp.)

  FDA approved Apotex Corp.'s supplemental application for aripiprazole, enabling the generic version to be marketed.

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• FDA approval · 2017-02-23
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application to authorize a generic aripiprazole product by Lannett Company, Inc. under ANDA204171.

• FDA approval · 2017-02-17
  FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Macleods Pharmaceuticals Limited's original application for ziprasidone hydrochloride, granting a generic version of ziprasidon…

• FDA approval · 2017-02-01
  FDA Approved: RISPERIDONE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for risperidone submitted by Ajanta Pharma USA Inc. The approval indicates updated labeling and pote…

• FDA approval · 2017-02-01
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for aripiprazole (generic ARIPIPRAZOLE) from Amneal Pharmaceuticals LLC, authorizing the generic for…

• FDA approval · 2017-01-13
  FDA Approved: SAPHRIS — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for SAPHRIS (asenapine) filed by Allergan, Inc., indicating an update to the product's labeling/indi…

• FDA approval · 2017-01-11
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

  FDA approved a supplemental application for LATUDA (lurasidone hydrochloride) submitted by Sumitomo Pharma America, Inc. to update labeling.

• FDA approval · 2016-12-27
  FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Original Application (BluePoint Laboratories)

  FDA approved BluePoint Laboratories' ziprasidone hydrochloride as a generic from an Abbreviated New Drug Application. The approval covers th…

• FDA approval · 2016-11-30
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  The FDA approved a supplemental application for Lamotrigine from Dr. Reddy's Laboratories Limited.

• FDA approval · 2016-11-08
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for carbamazepine submitted by Sun Pharmaceutical Industries, Inc., resulting in changes to the …

• FDA approval · 2016-11-08
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for carbamazepine submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2016-11-02
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a Supplemental Application for Depakote Sprinkles (divalproex sodium) submitted by AbbVie Inc.

• FDA approval · 2016-11-02
  FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote (divalproex sodium) from AbbVie Inc. The action updates labeling or indications related…

• FDA approval · 2016-11-01
  FDA Approved: QUETIAPINE FUMARATE — Original Application (Accord Healthcare Inc.)

  The FDA approved Accord Healthcare Inc.'s original application for quetiapine fumarate, granting marketing authorization for a generic versi…

• FDA approval · 2016-10-27
  FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2016-10-25
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for lithium carbonate submitted by Hikma Pharmaceuticals USA Inc., resulting in changes to the a…

• FDA approval · 2016-10-25
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Lithium Carbonate from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2016-10-18
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for aripiprazole from Torrent Pharmaceuticals Limited, enabling a generic version of the drug.

• FDA approval · 2016-10-07
  FDA Approved: ARIPIPRAZOLE — Original Application (Macleods Pharmaceuticals Limited)

  The FDA approved Macleods Pharmaceuticals Limited's generic aripiprazole (ANDA 204111) based on its original application.

• FDA approval · 2016-10-06
  FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Zyprexa Intramuscular (olanzapine) by Eli Lilly and Company to support the intramuscular for…

• FDA approval · 2016-09-29
  FDA Approved: LITHIUM CARBONATE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved the original application for a generic lithium carbonate product. The approval enables commercialization by Heritage Pharma…