Nsaid-induced Gastroduodenal Ulcers

• FDA approval · 2023-05-22
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' supplemental application for esomeprazole magnesium delayed-release capsules (generic esomeprazole mag…

• FDA approval · 2020-09-11
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Prevacid Solutab (lansoprazole) from Takeda Pharmaceuticals America, Inc., related to the So…

• FDA approval · 2019-04-04
  FDA Approved: NEXIUM 24HR CLEARMINIS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for NEXIUM 24HR CLEARMINIS (esomeprazole magnesium) filed by Haleon US Holdings LLC.

• FDA approval · 2017-07-03
  FDA Approved: OMEPRAZOLE — Original Application (Golden State Medical Supply, Inc.)

  FDA approves a generic omeprazole from Golden State Medical Supply, Inc. under an Original Application (ANDA 203481).

• FDA approval · 2016-12-01
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  The FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) from AmerisourceBergen, updating labeling and…

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• FDA approval · 2016-10-14
  FDA Approved: LANSOPRAZOLE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s generic lansoprazole under an original ANDA.

• FDA approval · 2015-03-02
  FDA Approved: OMEPRAZOLE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for omeprazole from Zydus Lifesciences Limited under the ANDA.

• FDA approval · 2015-01-02
  FDA Approved: OMEPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approves a supplemental application for omeprazole from Quallent Pharmaceuticals Health LLC, authorizing an additional formulation/produ…

• FDA approval · 2014-12-12
  FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)

  The FDA approved Apotex Corp's supplemental application for a generic omeprazole product.

• 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 · 2007-04-27
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca, resulting in updated labeling.