Bipolar Disorder Depressive Episode

• FDA approval · 2025-08-12
  FDA Approved: LURASIDONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Lurasidone hydrochloride submitted by Sun Pharmaceutical Industries, Inc. The action relates…

• FDA approval · 2025-01-13
  FDA Approved: LURASIDONE HYDROCHLORIDE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Lurasidone hydrochloride from Torrent Pharmaceuticals Limited as an original generic drug application (ANDA 208055).

• FDA approval · 2023-07-21
  FDA Approved: LURASIDONE HYDROCHLORIDE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental ANDA for Lurasidone hydrochloride from Zydus Pharmaceuticals USA Inc., enabling the marketing of a generic versi…

• FDA approval · 2021-08-24
  FDA Approved: LURASIDONE HYDROCHLORIDE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's original application for lurasidone hydrochloride tablets as a generic treatment for schizoph…

• 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…

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