Headache

• FDA approval · 2012-03-15
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to add Aleve GelCaps containing naproxen sodium, expanding the approval to include a new dosage form…

• FDA approval · 2011-06-22
  FDA Approved: BUTALBITAL AND ACETAMINOPHEN — Supplemental Application (Endo USA)

  FDA approved a supplemental application for butalbital and acetaminophen (Endo USA), approving changes to the product's labeling.

• FDA approval · 2010-11-22
  FDA Approved: IBUPROFEN, DIPHENHYDRAMINE HCL — Original Application (Bionpharma Inc.)

  FDA approved the original application for a combination product of ibuprofen and diphenhydramine HCl by Bionpharma Inc., intended for tempor…

• FDA approval · 2010-05-27
  FDA Approved: ADVIL SINUS CONGESTION AND PAIN — Original Application (Haleon US Holdings LLC)

  FDA approves Advil Sinus Congestion and Pain as an original application, combining ibuprofen with phenylephrine hydrochloride to provide tem…

• FDA approval · 2009-06-22
  FDA Approved: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for the combination product Butalbital, Acetaminophen and Caffeine (Butalbital/acetaminophen/caffein…

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• FDA approval · 2008-08-22
  FDA Approved: GOOD SENSE CHILDRENS IBUPROFEN — Supplemental Application (L. Perrigo Company)

  FDA approved a supplemental application for Good Sense Children’s Ibuprofen (ibuprofen) from L. Perrigo Company.

• FDA approval · 2008-06-20
  FDA Approved: JUNIOR STRENGTH ADVIL — Supplemental Application (Haleon US Holdings LLC)

  FDA approves a supplemental application for JUNIOR STRENGTH ADVIL (ibuprofen) from Haleon US Holdings LLC.

• FDA approval · 2007-11-09
  FDA Approved: BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE — Supplemental Application (Amneal Pharmaceuticals of New York, LLC)

  FDA approved a supplemental application for the generic formulation of Butalbital, Aspirin, Caffeine and Codeine Phosphate by Amneal Pharmac…