Peptic Ulcer Disease

• FDA label_change · 2022-03-04
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca Pharmaceuticals LP.

• 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…

• 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.

• FDA label_change · 2018-02-28
  FDA Approved: CYTOTEC — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Cytotec (misoprostol) from Pfizer, resulting in an update to the product labeling.

• FDA label_change · 2017-01-13
  FDA Approved: LIBRAX — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for Librax (chlordiazepoxide hydrochloride and clidinium bromide) submitted by Bausch Health US, LLC…

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• FDA label_change · 2016-12-19
  FDA Approved: CYTOTEC — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Cytotec (misoprostol) from Pfizer Laboratories Div Pfizer Inc, resulting in a labeling update.

• 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 · 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 · 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 · 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 …