Migraine

• FDA approval · 2008-07-29
  FDA Approved: DIVALPROEX SODIUM — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approved a generic version of divalproex sodium from Dr. Reddy's Laboratories Limited under an Original Application (ANDA).

• FDA approval · 2008-04-15
  FDA Approved: TREXIMET — Original Application (Currax Pharmaceuticals LLC)

  FDA approved TREXIMET, a fixed-dose combination of sumatriptan succinate and naproxen sodium, under an original application by Currax Pharma…

• FDA approval · 2008-04-14
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Amitriptyline Hydrochloride from Aurobindo Pharma Limited, indicating regulatory clearance for a…

• FDA approval · 2008-03-24
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA has approved a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie.

• FDA approval · 2008-03-24
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie. The approval covers changes to Depakote ER'…

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• FDA approval · 2008-03-20
  FDA Approved: BUTALBITAL, ASPIRIN, AND CAFFEINE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved a supplemental application for the combination product butalbital, aspirin, and caffeine from Westminster Pharmaceuticals, LLC.

• FDA approval · 2008-03-20
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approves a supplemental application for propranolol hydrochloride from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2008-03-20
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for propranolol hydrochloride from Amneal Pharmaceuticals NY LLC, signifying approval of a gener…

• FDA approval · 2008-03-05
  FDA Approved: DG HEALTH MIGRAINE RELIEF — Supplemental Application (Dolgencorp, LLC)

  FDA approved a supplemental application for DG HEALTH MIGRAINE RELIEF, an OTC combination product containing acetaminophen, aspirin, and caf…

• FDA approval · 2008-01-07
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for propranolol hydrochloride from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2007-08-10
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)

  The FDA approved Actavis Pharma's generic propranolol hydrochloride product in an Original ANDA submission.

• FDA approval · 2007-06-29
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Amitriptyline hydrochloride from Sandoz Inc., enabling regulatory clearance for this generic pro…

• FDA approval · 2007-01-31
  FDA Approved: EXCEDRIN MIGRAINE GELTABS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Excedrin Migraine GelTabs, a gel-tab formulation containing acetaminophen, aspirin, and caffeine…

• FDA approval · 2007-01-03
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INDERAL LA (propranolol hydrochloride) submitted by ANI Pharmaceuticals, Inc. This action au…

• FDA approval · 2006-12-17
  FDA Approved: VALPROIC ACID — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for valproic acid submitted by Bionpharma Inc.

• FDA approval · 2006-11-21
  FDA Approved: DG HEALTH MIGRAINE RELIEF — Supplemental Application (Dolgencorp, LLC)

  The FDA approved a supplemental application for DG Health Migraine Relief, an over-the-counter product containing acetaminophen, aspirin, an…

• FDA approval · 2006-10-19
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TOPAMAX (topiramate) submitted by Janssen Pharmaceuticals, Inc.

• FDA approval · 2006-10-13
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie. The action updates labeling to reflect the a…

• FDA approval · 2006-08-22
  FDA Approved: VALPROIC ACID — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for valproic acid from ANI Pharmaceuticals, indicating an approved change related to its product…