Helicobacter Pylori Infection

• 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 · 2021-03-05
  FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental application for the combination product Bismuth subcitrate potassium, metronidazole and tetracycline hydrochlori…

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• FDA label_change · 2020-11-27
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• 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 · 2013-12-10
  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) to update the product labeling. The sponsor is Wy…

• 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 · 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 · 2007-05-24
  FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)

  The FDA approved a supplemental application for the combination drug Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochlor…