Duodenal Ulcer

• FDA label_change · 2025-04-25
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for pantoprazole sodium by Eugia US LLC, resulting in a labeling update for the product.

• FDA label_change · 2024-09-16
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for lansoprazole from Zydus Pharmaceuticals USA Inc., resulting in updated labeling for the prod…

• FDA label_change · 2023-07-18
  FDA Approved: OMEPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for omeprazole, resulting in updated labeling for the product. This is a s…

• FDA label_change · 2022-09-27
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for pantoprazole sodium from Sun Pharmaceutical Industries, resulting in an updated labeling for the…

• FDA label_change · 2020-05-13
  FDA Approved: FAMOTIDINE — Supplemental Application (Carlsbad Technology, Inc)

  FDA approved a supplemental application for famotidine (Carlsbad Technology, Inc.), resulting in changes to its labeling.

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• FDA label_change · 2020-01-07
  FDA Approved: FAMOTIDINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA notes a supplemental application for famotidine by Lupin Pharmaceuticals, likely involving labeling changes for the drug.

• FDA label_change · 2015-03-16
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for lansoprazole submitted by Mylan Pharmaceuticals, indicating a change to the product labeling/aut…

• FDA label_change · 2014-10-15
  FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC to update the labeling.

• FDA label_change · 2013-09-13
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  The FDA lists a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) from AmerisourceBergen, typically related to lab…

• FDA label_change · 2012-12-20
  FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Dexilant (lansoprazole) filed by Takeda, extending its labeling with additional indications.

• FDA label_change · 2012-05-18
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for Pantoprazole Sodium (Lannett Company) under ANDA 078281, signaling changes to the labeling f…

• FDA label_change · 2011-05-20
  FDA Approved: PROTONIX DELAYED-RELEASE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for PROTONIX DELAYED-RELEASE (pantoprazole sodium) from Wyeth/Pfizer to update the product labeling.

• FDA label_change · 2011-05-20
  FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC to update the product labeling…

• FDA label_change · 2010-07-16
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  The FDA approved a labeling supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) from AmerisourceBergen. The update m…

• FDA label_change · 2009-05-28
  FDA Approved: RANITIDINE — Supplemental Application (Pharmaceutical Associates, Inc.)

  The FDA approved a supplemental application for ranitidine from Pharmaceutical Associates, Inc., indicating a labeling or related change to …