Absence Seizures

• FDA approval · 2025-08-01
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for Ethosuximide submitted by PAI Holdings, LLC dba PAI Pharma. The action updates the regulatory st…

• FDA approval · 2023-05-01
  FDA Approved: METHSUXIMIDE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' original application for methsuximide, a generic anticonvulsant used to treat absence seizures.

• FDA approval · 2022-08-25
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Ethosuximide submitted by Strides Pharma Science Limited.

• FDA approval · 2022-08-16
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for Ethosuximide filed by Epic Pharma, LLC.

• FDA approval · 2022-02-22
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for ethosuximide from Chartwell RX, LLC, indicating regulatory approval of a change to the approved …

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• FDA approval · 2022-02-16
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for Ethosuximide from Bionpharma Inc., indicating regulatory changes were approved for this prod…

• FDA approval · 2021-10-29
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Zarontin (ethosuximide) from Parke-Davis Div of Pfizer Inc.

• FDA approval · 2021-10-28
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for Zarontin (ethosuximide) submitted by Parke-Davis Div of Pfizer Inc.

• FDA approval · 2020-04-01
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Ethosuximide from Bionpharma Inc.

• FDA approval · 2020-03-16
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for ethosuximide submitted by Chartwell RX, LLC, under the ANDA program.

• FDA approval · 2020-03-16
  FDA Approved: ETHOSUXIMIDE — Original Application (Epic Pharma, LLC)

  FDA approved Ethosuximide from Epic Pharma, LLC under an Abbreviated New Drug Application. It is approved as a generic treatment for absence…

• FDA approval · 2019-02-19
  FDA Approved: ETHOSUXIMIDE — Original Application (Strides Pharma Science Limited)

  FDA approves Strides Pharma Science Limited's original ANDA for ethosuximide, a generic treatment for absence seizures in epilepsy.

• FDA approval · 2017-05-05
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for Ethosuximide (PAI Pharma) to update the product labeling.

• FDA approval · 2016-05-17
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for Zarontin (ethosuximide) from Parke-Davis Div. of Pfizer Inc., indicating approved changes to the…

• FDA approval · 2014-01-16
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Zarontin (ethosuximide) submitted by Parke-Davis Div of Pfizer Inc, reflecting an approved m…

• FDA approval · 2014-01-15
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for Ethosuximide from PAI Holdings, LLC dba PAI Pharma.

• FDA approval · 2014-01-07
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for Ethosuximide from Bionpharma Inc. under ANDA040430.

• FDA approval · 2012-10-25
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for Zarontin (ethosuximide) from Parke-Davis Div of Pfizer Inc, indicating approval of changes to th…

• FDA approval · 2012-10-25
  FDA Approved: CLONAZEPAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for clonazepam from Aurobindo Pharma Limited under an ANDA, confirming continued availability of thi…

• FDA approval · 2012-10-19
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for Ethosuximide from Bionpharma Inc., confirming its use in treating absence seizures associate…

• FDA approval · 2012-09-25
  FDA Approved: ETHOSUXIMIDE — Original Application (Chartwell RX, LLC)

  FDA approved Ethosuximide as an original generic (ANDA) for Chartwell RX, LLC.

• FDA approval · 2012-05-03
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Zarontin (ethosuximide) submitted by Parke-Davis Div of Pfizer Inc.

• FDA approval · 2011-12-27
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Ethosuximide by Bionpharma Inc., marking a supplemental regulatory action under ANDA 040430. The…

• FDA approval · 2011-06-15
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Zarontin (ethosuximide) from Parke-Davis (Pfizer), indicating approval of changes to its lab…

• FDA approval · 2011-06-15
  FDA Approved: CELONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Celontin (methsuximide) submitted by Parke-Davis Div of Pfizer Inc. The action pertains to a…