Zollinger-ellison Syndrome

• FDA approval · 2011-01-06
  FDA Approved: FAMOTIDINE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for famotidine submitted by Baxter Healthcare Corporation, resulting in a label change for the produ…

• FDA approval · 2010-11-23
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Omeprazole from Sandoz Inc, granting approval for this generic proton pump inhibitor under an AN…

• FDA approval · 2010-11-17
  FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for the generic omeprazole from Lannett Company, Inc., authorizing continued marketing under the…

• FDA approval · 2010-10-29
  FDA Approved: FAMOTIDINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  The FDA approved a supplemental application for famotidine from Dr. Reddy's Laboratories Limited, authorizing a modification to an existing …

• FDA approval · 2010-09-03
  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 Pfizer subs…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2010-09-03
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  The FDA approved Oceanside Pharmaceuticals' supplemental application for Omeprazole and Sodium Bicarbonate.

• FDA approval · 2010-09-03
  FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for Prilosec (omeprazole magnesium) submitted by Covis Pharma US, Inc., representing a labeling amen…

• FDA approval · 2010-01-31
  FDA Approved: RANITIDINE — Supplemental Application (Pharmaceutical Associates, Inc.)

  The FDA approved a supplemental application for ranitidine filed by Pharmaceutical Associates, Inc., updating the drug's labeling. This acti…

• FDA approval · 2009-09-21
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  The FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole). This action typically updates labeling, manu…

• 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 · 2009-04-06
  FDA Approved: RANITIDINE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for ranitidine submitted by Dr. Reddy's Laboratories Limited.

• 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.

• 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 · 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 · 2007-11-14
  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 (Quallent Pharmaceuticals Health LLC)

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

• FDA approval · 2007-03-21
  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 · 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…