Bipolar Disorder Depressive Episodes

• FDA approval · 2024-08-21
  FDA Approved: LURASIDONE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for a generic Lurasidone hydrochloride product, authorizing a generic version of l…

• 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 label_change · 2016-03-29
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

  The FDA approved a supplemental application for LATUDA (lurasidone hydrochloride) submitted by Sumitomo Pharma America, Inc., resulting in a…

• FDA approval · 2015-01-05
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

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

• FDA approval · 2014-02-28
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

  FDA approved a supplemental application for LATUDA (lurasidone hydrochloride) submitted by Sumitomo Pharma America, Inc., resulting in an ap…

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• FDA approval · 2013-01-22
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

  The FDA approved a supplemental application for Latuda (lurasidone hydrochloride) from Sumitomo Pharma America, Inc. to update the product l…