Peptic Ulcer Disease

• FDA approval · 2008-06-30
  FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC.

• FDA approval · 2008-03-20
  FDA Approved: RANITIDINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for ranitidine from Amneal Pharmaceuticals of New York LLC, authorizing the continued marketing of a…

• FDA approval · 2008-02-27
  FDA Approved: FAMOTIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for famotidine from Teva Pharmaceuticals USA, Inc., updating the approved generic product.

• FDA approval · 2007-12-21
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for the combination product omeprazole and sodium bicarbonate from Oceanside Pharmaceuticals.

• FDA approval · 2007-12-20
  FDA Approved: PROTONIX DELAYED-RELEASE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application for PROTONIX DELAYED-RELEASE (pantoprazole sodium) from Wyeth Pharmaceuticals LLC, a subsidiary …

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• FDA approval · 2007-08-31
  FDA Approved: RANITIDINE — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved the original ANDA for ranitidine from Dr. Reddy's Laboratories Limited, enabling a generic ranitidine product to be marketed in…

• FDA approval · 2007-08-20
  FDA Approved: CLARITHROMYCIN — Original Application (Chartwell RX, LLC.)

  FDA approved a generic version of clarithromycin from Chartwell RX, LLC through an Original Abbreviated New Drug Application (ANDA).

• FDA approval · 2007-04-26
  FDA Approved: CARAFATE — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for CARAFATE (sucralfate) from Allergan, Inc., resulting in updated labeling and/or indication infor…

• FDA approval · 2006-10-13
  FDA Approved: RANITIDINE — Original Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved Amneal Pharmaceuticals of New York LLC's original application for generic ranitidine, authorizing its commercial ranitidine…

• FDA approval · 2006-09-25
  FDA Approved: FAMOTIDINE — Original Application (Chain Drug Consortium, LLC)

  The FDA approved Chain Drug Consortium, LLC's original application for famotidine, enabling a generic version of famotidine to be marketed. …

• FDA approval · 2006-07-25
  FDA Approved: PROTONIX DELAYED-RELEASE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application for Protonix Delayed-Release (pantoprazole sodium) submitted by Wyeth Pharmaceuticals LLC, a sub…