Erosive Esophagitis

• FDA approval · 2009-06-18
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP to update the la…

• FDA approval · 2009-04-02
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole), enabling continued marketing of the product unde…

• FDA approval · 2009-02-27
  FDA Approved: CIMETIDINE 200 ACID REDUCER — Supplemental Application (Walgreen Company)

  FDA approved a supplemental application to approve Walgreens' Cimetidine 200 Acid Reducer as a generic cimetidine product.

• FDA approval · 2009-01-30
  FDA Approved: DEXILANT — Original Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved Dexilant (dexlansoprazole) under an original application for the treatment of gastroesophageal reflux disease, including healin…

• FDA approval · 2009-01-21
  FDA Approved: OMEPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for omeprazole filed by Quallent Pharmaceuticals Health LLC under an ANDA.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2009-01-21
  FDA Approved: OMEPRAZOLE — Original Application (Sandoz Inc)

  FDA approved the original application for omeprazole from Sandoz Inc, authorizing a generic version of this proton pump inhibitor.

• FDA approval · 2008-12-01
  FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for Prilosec (omeprazole magnesium) by Covis Pharma US, Inc. to update and/or expand the product lab…

• FDA approval · 2008-11-24
  FDA Approved: ACID CONTROLLER — Supplemental Application (H E B)

  FDA approved a supplemental application for ACID CONTROLLER (famotidine) from H E B. The approval expands the product's labeling/indications…

• 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 · 2008-06-25
  FDA Approved: FAMOTIDINE — Original Application (Mylan Institutional LLC)

  The FDA approved a generic famotidine product from Mylan Institutional LLC under an original ANDA.

• FDA approval · 2008-06-03
  FDA Approved: FAMOTIDINE — Supplemental Application (Sagent Pharmaceuticals)

  The FDA approved Sagent Pharmaceuticals' supplemental application for famotidine under an existing ANDA, updating the product's approved lab…

• FDA approval · 2008-06-03
  FDA Approved: FAMOTIDINE — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for famotidine from Sagent Pharmaceuticals, confirming the generic product under ANDA075651.

• FDA approval · 2008-05-20
  FDA Approved: FAMOTIDINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for famotidine (Hikma Pharmaceuticals USA Inc.). The approval updates the labeling to reflect additi…

• FDA approval · 2008-04-21
  FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for PREVACID (lansoprazole) filed by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2008-04-21
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approves a supplemental application for PREVACID SOLUTAB (lansoprazole) filed by Takeda Pharmaceuticals America, expanding the product's…

• 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 …

• 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.