Epilepsy

• FDA approval · 2011-07-14
  FDA Approved: ACETAZOLAMIDE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved the original ANDA for Acetazolamide from Westminster Pharmaceuticals, making a generic version of the carbonic anhydrase inhibi…

• FDA approval · 2011-07-07
  FDA Approved: TOPIRAMATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Topiramate by Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2011-06-27
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for TOPAMAX (topiramate) filed by Janssen Pharmaceuticals, Inc., to update/expand the approved label…

• FDA approval · 2011-06-24
  FDA Approved: TOPIRAMATE — Supplemental Application (Cipla USA Inc.)

  The FDA approved a supplemental application for TOPIRAMATE (Cipla USA Inc.), authorizing changes to the product labeling under the ANDA.

• FDA approval · 2011-06-24
  FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Topiramate by Zydus Lifesciences Limited.

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• FDA approval · 2011-06-24
  FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Topiramate from Zydus Lifesciences Limited, updating the approved generic Topiramate product. Th…

• FDA approval · 2011-06-21
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal XR (lamotrigine) from GlaxoSmithKline LLC. The approval updates the labeling/indication…

• 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…

• FDA approval · 2011-05-31
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) submitted by GlaxoSmithKline LLC.

• FDA approval · 2011-05-27
  FDA Approved: ZONEGRAN — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approved a supplemental application for ZONEGRAN (zonisamide) submitted by Advanz Pharma (US) Corp. under NDA 020789.

• FDA approval · 2011-05-27
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2011-05-20
  FDA Approved: CARBAMAZEPINE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approves ANI Pharmaceuticals' original application to market a generic carbamazepine formulation under an ANDA.

• FDA approval · 2011-04-26
  FDA Approved: LYRICA — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for LYRICA (pregabalin) filed by Parke-Davis Div of Pfizer Inc.

• FDA approval · 2011-04-25
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Lamictal XR (lamotrigine) by GlaxoSmithKline LLC.

• FDA approval · 2011-04-08
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Dilantin (extended phenytoin sodium) filed by Viatris Specialty LLC.

• FDA approval · 2011-04-08
  FDA Approved: PHENYTOIN INFATABS — Supplemental Application (Prasco Laboratories)

  FDA entry documents a supplemental application for Phenytoin Infatabs (phenytoin) from Prasco Laboratories under ANDA 084427.

• FDA approval · 2011-04-08
  FDA Approved: CLONAZEPAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for clonazepam filed by Aurobindo Pharma Limited under ANDA075150.

• FDA approval · 2011-04-05
  FDA Approved: DIVALPROEX SODIUM — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved the generic divalproex sodium from Unichem Pharmaceuticals (USA), Inc. under ANDA079163.

• FDA approval · 2011-03-30
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Lamotrigine from Aurobindo Pharma Limited. This approval confirms the availability of the lamotr…

• FDA approval · 2011-03-30
  FDA Approved: GABAPENTIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for gabapentin from Sun Pharmaceutical Industries, Inc. (ANDA077242), confirming regulatory approval…

• FDA approval · 2011-03-30
  FDA Approved: PRIMIDONE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Primidone (PRIMIDONE) from Actavis Pharma, Inc. The action indicates regulatory approval under t…

• FDA approval · 2011-03-30
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for gabapentin from Amneal Pharmaceuticals LLC. This entry reflects a supplemental approval of a gen…

• FDA approval · 2011-03-29
  FDA Approved: PRIMIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Primidone from Amneal Pharmaceuticals LLC.

• FDA approval · 2011-03-29
  FDA Approved: PRIMIDONE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application for Primidone submitted by Oxford Pharmaceuticals, LLC.