Bipolar Ii Disorder

• FDA approval · 2026-04-22
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for quetiapine fumarate from Accord Healthcare Inc., updating the product's labeling and/or indicati…

• FDA approval · 2023-06-07
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Quetiapine Fumarate by Macleods Pharmaceuticals Limited under ANDA203359.

• FDA approval · 2022-04-05
  FDA Approved: IGALMI — Original Application (BioXcel Therapeutics, Inc.)

  FDA approves IGALMI (dexmedetomidine) by BioXcel Therapeutics for the acute treatment of agitation in adults with schizophrenia or bipolar I…

• 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 · 2018-12-20
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for lithium carbonate filed by Rising Pharma Holdings, Inc., indicating an approved modification…

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• 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 · 2015-09-04
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for quetiapine fumarate from Hikma Pharmaceuticals USA, indicating approval of changes to the pr…

• FDA approval · 2014-04-22
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for quetiapine fumarate submitted by BluePoint Laboratories. This action grants updated regulatory a…