Gastric Ulcers

• FDA approval · 2024-12-10
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for esomeprazole magnesium from Ascend Laboratories, LLC, under an approved ANDA.

• FDA approval · 2024-11-22
  FDA Approved: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s supplemental application for Naproxen and Esomeprazole Magnesium (ANDA 213699), establishing a generic…

• FDA approval · 2024-03-05
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for pantoprazole sodium submitted by Eugia US LLC.

• FDA approval · 2024-02-01
  FDA Approved: METHSCOPOLAMINE BROMIDE — Original Application (i3 Pharmaceuticals, LLC)

  FDA approved the original application for methscopolamine bromide, a generic anticholinergic agent, filed by i3 Pharmaceuticals, LLC.

• FDA approval · 2023-12-20
  FDA Approved: FAMOTIDINE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approves Westminster Pharmaceuticals' original ANDA for famotidine, a generic H2 blocker used to treat ulcers and GERD.

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• FDA approval · 2023-10-18
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved Granules Pharmaceuticals' original application for esomeprazole magnesium, a proton pump inhibitor, as a generic drug. It is in…

• FDA approval · 2023-06-16
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Edenbridge Pharmaceuticals LLC.)

  FDA approves Edenbridge Pharmaceuticals' pantoprazole sodium generic under an Original Application (ANDA).

• FDA approval · 2022-10-17
  FDA Approved: MISOPROSTOL — Original Application (Micro Labs Limited)

  The FDA approved an original application for a generic misoprostol product from Micro Labs Limited.

• FDA approval · 2022-08-04
  FDA Approved: FAMOTIDINE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approves Amneal's original application for famotidine, enabling a generic version of the H2 blocker. The approval covers common indicati…

• FDA approval · 2022-05-19
  FDA Approved: PANTOPRAZOLE SODIUM I.V. — Original Application (Piramal Critical Care)

  FDA approved Pantoprazole sodium for injection (IV) from Piramal Critical Care under an original application.

• FDA approval · 2022-02-18
  FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for PEPCID AC MAXIMUM STRENGTH (famotidine) from Kenvue Brands LLC.

• FDA approval · 2020-02-18
  FDA Approved: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited for Naproxen and Esomeprazole Magnesium under an Original Application (ANDA) for a generic Nap…

• FDA approval · 2019-11-14
  FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)

  FDA approved a Supplemental Application for Pantoprazole from NorthStar RxLLC, indicating an approved revision or addition to this generic p…

• FDA approval · 2018-06-07
  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) submitted by Wyeth Pharmaceuticals LLC (Pfize…

• FDA approval · 2017-02-07
  FDA Approved: RANITIDINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for ranitidine from Amneal Pharmaceuticals of New York LLC (ANDA 077824).

• FDA approval · 2016-04-22
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for Esomeprazole Magnesium (generic esomeprazole magnesium) submitted by NorthStar Rx LLC.

• FDA approval · 2012-09-28
  FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application to add an intravenous formulation of pantoprazole (PROTONIX I.V.) from Wyeth Pharmaceuticals (Pf…

• FDA approval · 2012-01-20
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP.

• 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 · 2009-08-31
  FDA Approved: RANITIDINE — Supplemental Application (Dr. Reddy's Laboratories Limited)

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

• FDA approval · 2008-03-20
  FDA Approved: RANITIDINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for ranitidine from Amneal Pharmaceuticals of New York LLC, authorizing the continued marketing of a…

• FDA approval · 2007-08-24
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for the Diclofenac sodium and misoprostol combination product from Mylan Pharmaceuticals.