Cerebral Vasospasm

• FDA approval · 2025-10-22
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Caplin Steriles Limited)

  FDA approves an original ANDA for Nicardipine Hydrochloride as a generic product by Caplin Steriles Limited.

• FDA approval · 2024-08-28
  FDA Approved: NYMALIZE — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for NYMALIZE (nimodipine) from Azurity Pharmaceuticals, Inc.

• FDA approval · 2015-08-26
  FDA Approved: NYMALIZE — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  FDA approved a supplemental application for NYMALIZE (nimodipine) by Azurity Pharmaceuticals, Inc.

• FDA approval · 2013-06-21
  FDA Approved: NIMODIPINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for nimodipine from Heritage Pharmaceuticals (Avet), marking approval of an additional generic p…

• FDA approval · 2009-11-17
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Civica, Inc.)

  FDA approved Civica, Inc.'s nicardipine hydrochloride as an original generic application (ANDA 090534), making a generic version of this cal…

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• FDA approval · 2008-01-17
  FDA Approved: NIMODIPINE — Original Application (BIONPHARMA INC.)

  FDA approves Bionpharma's nimodipine generic under an original ANDA, enabling market entry for this calcium channel blocker. Nimodipine is i…

• FDA approval · 2007-05-02
  FDA Approved: NIMODIPINE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved the original application for nimodipine as a generic product from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.…