Erosive Esophagitis

• 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: NEXIUM — Original Application (AstraZeneca Pharmaceuticals LP)

  FDA approved Nexium (esomeprazole magnesium) through its Original Application, marking its original approval as a proton pump inhibitor for …

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

  FDA approved a supplemental application to add an intravenous form of pantoprazole (PROTONIX I.V.), expanding the approved route of administ…

• FDA approval · 2007-11-14
  FDA Approved: PROTONIX DELAYED-RELEASE — Original Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved the original application for Pantoprazole sodium delayed-release (Protonix Delayed-Release) by Wyeth/Pfizer for the treatment o…

• FDA approval · 2007-10-22
  FDA Approved: OMEPRAZOLE — Original Application (Apotex Corp)

  FDA approved Apotex Corp's original application for a generic omeprazole product, enabling a generic option for treating gastroesophageal re…

• FDA approval · 2007-10-22
  FDA Approved: OMEPRAZOLE — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved the original (ANDA) application for omeprazole from Quallent Pharmaceuticals Health LLC, authorizing a generic omeprazole produ…

• FDA approval · 2007-09-21
  FDA Approved: RANITIDINE — Original Application (Pharmaceutical Associates, Inc.)

  FDA approved an original application for ranitidine (generic) by Pharmaceutical Associates, Inc.

• FDA approval · 2007-04-27
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca, resulting in updated labeling.

• FDA approval · 2007-03-21
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for omeprazole by Sandoz Inc. This action updates the current approval for this generic drug.

• FDA approval · 2007-03-16
  FDA Approved: CIMETIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for cimetidine, approving changes to its labeling/indication. This update broadens or clarifies…

• FDA approval · 2006-10-20
  FDA Approved: NEXIUM — Original Application (AstraZeneca Pharmaceuticals LP)

  FDA approved Nexium (esomeprazole magnesium) as AstraZeneca's original NDA. The approval established Nexium as a proton pump inhibitor for a…

• 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 · 2006-09-26
  FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for omeprazole from Lannett Company, Inc., enabling the marketing of the generic omeprazole product.

• 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…

• FDA approval · 2006-06-09
  FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Pepcid AC Maximum Strength (famotidine) by Kenvue Brands LLC, supporting a higher-strength formu…