Migraine Prophylaxis

• FDA approval · 2024-06-24
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (Lifestar Pharma LLC)

  FDA approved a supplemental application for Amitriptyline Hydrochloride by Lifestar Pharma LLC. The submission status is AP.

• CLINICAL_TRIALS trial_result · 2022-07-20
  Clinical Trial Update: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Subcutaneous AGX-201 for Migraine Prophylaxis [Phase 2]

  Phase 2 randomized trial evaluating subcutaneous AGX-201 for migraine prophylaxis; current status not specified.

• FDA approval · 2015-12-21
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Inderal LA (propranolol hydrochloride) by ANI Pharmaceuticals, Inc., granting approval for chang…

• FDA approval · 2014-12-09
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental ANDA for propranolol hydrochloride by Amneal Pharmaceuticals NY LLC, authorizing a new generic propranolol hydro…

• FDA approval · 2012-01-27
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Endo USA, Inc.)

  FDA approved Endo USA, Inc.'s supplemental application for propranolol hydrochloride, indicating the generic product's supplemental filing h…

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• FDA approval · 2008-09-10
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for propranolol hydrochloride from Hikma Pharmaceuticals USA Inc., indicating regulatory approval of…

• FDA approval · 2008-01-31
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a generic version of propranolol hydrochloride for the same indications as the brand product, enabling generic competition for …

• FDA approval · 2007-06-21
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for propranolol hydrochloride (generic) from Hikma Pharmaceuticals USA Inc., indicating an approval …