Seizure Disorders

• FDA approval · 2013-09-25
  FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for fosphenytoin sodium by Hikma Pharmaceuticals USA Inc., approving changes to the approved product…

• FDA approval · 2013-09-06
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DILANTIN-125 (phenytoin) from Viatris Specialty LLC.

• FDA approval · 2013-08-22
  FDA Approved: FOSPHENYTOIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Fosphenytoin Sodium (Fosphenytoin) by Fresenius Kabi USA, LLC.

• FDA approval · 2013-07-25
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Keppra (levetiracetam) submitted by UCB, Inc., authorizing changes to the drug's labeling.

• FDA approval · 2013-01-28
  FDA Approved: DIAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for diazepam from Teva Pharmaceuticals USA, Inc., indicating an updated approval-related action for …

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• FDA approval · 2012-11-09
  FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)

  FDA approved a supplemental application for levetiracetam filed by WG Critical Care, LLC.

• FDA approval · 2012-04-11
  FDA Approved: LEVETIRACETAM — Original Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approved the original application for levetiracetam by Quagen Pharmaceuticals LLC, making a generic version of the antiepileptic availab…

• FDA approval · 2011-11-09
  FDA Approved: LEVETIRACETAM — Original Application (WG Critical Care, LLC)

  The FDA approved an original application for levetiracetam from WG Critical Care, LLC.

• FDA approval · 2011-09-15
  FDA Approved: CLONAZEPAM — Supplemental Application (Solco Healthcare LLC)

  FDA approved Solco Healthcare LLC's supplemental application for clonazepam under an approved ANDA.

• FDA approval · 2010-02-26
  FDA Approved: ZONISAMIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for zonisamide submitted by Aurobindo Pharma Limited. The approval confirms the changes requeste…

• FDA approval · 2009-12-23
  FDA Approved: LORAZEPAM — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal Pharmaceuticals' generic lorazepam (oral) under an Original Application (ANDA 091383).

• FDA approval · 2009-12-15
  FDA Approved: PHENYTOIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2009-10-15
  FDA Approved: CLONAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for clonazepam filed by Teva Pharmaceuticals USA, Inc., indicating an update under the approved …

• FDA approval · 2009-05-07
  FDA Approved: CLONAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for clonazepam submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2009-01-16
  FDA Approved: LEVETIRACETAM — Original Application (Bionpharma Inc.)

  FDA approved a generic levetiracetam product from Bionpharma Inc. under an Original Application (ANDA 079120), expanding access to this anti…

• FDA approval · 2009-01-15
  FDA Approved: LEVETIRACETAM — Original Application (Patrin Pharma, Inc.)

  FDA approved a generic version of levetiracetam under an original ANDA from Patrin Pharma, Inc. This marks the availability of a generic alt…

• FDA approval · 2009-01-15
  FDA Approved: LEVETIRACETAM — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's original application for levetiracetam, granting approval of a generic version of the antisei…

• FDA approval · 2008-11-04
  FDA Approved: LEVETIRACETAM — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original application for a generic version of levetiracetam by Mylan Pharmaceuticals Inc.

• FDA approval · 2007-07-09
  FDA Approved: CLONAZEPAM — Supplemental Application (Solco Healthcare LLC)

  FDA granted a supplemental approval for clonazepam from Solco Healthcare LLC under ANDA077856.

• FDA approval · 2006-11-29
  FDA Approved: LORAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lorazepam by Hikma Pharmaceuticals USA Inc., authorizing modifications under the supplement.

• FDA approval · 2006-09-13
  FDA Approved: PHENYTOIN SODIUM — Original Application (Acella Pharmaceuticals, LLC)

  FDA approves Acella Pharmaceuticals' phenytoin sodium generic under an original ANDA for seizure disorders. This marks the introduction of a…