Duodenal Ulcer

• FDA approval · 2024-11-13
  FDA Approved: SUCRALFATE — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approves Cosette Pharmaceuticals' generic sucralfate under an original ANDA for short-term treatment and maintenance of duodenal ulcers …

• FDA approval · 2024-11-12
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for esomeprazole magnesium from Mylan Pharmaceuticals, enabling the generic product to be marketed w…

• FDA approval · 2024-11-12
  FDA Approved: CIMETIDINE — Original Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma Limited's original application for cimetidine (generic cimetidine), authorizing its marketing as a generic H2 …

• FDA approval · 2024-11-08
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) submitted by Amerisource Bergen.

• FDA approval · 2024-11-08
  FDA Approved: ACID REDUCER — Supplemental Application (WALGREEN CO.)

  FDA approves a supplemental application for ACID REDUCER (omeprazole) from Walgreens Co., under ANDA206877.

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• FDA approval · 2024-11-07
  FDA Approved: CIMETIDINE — Original Application (Bionpharma Inc.)

  FDA approved Bionpharma Inc.'s Original Application for cimetidine, enabling the marketing of a generic H2 blocker. The action establishes a…

• FDA approval · 2024-11-05
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for rabeprazole sodium (Amneal Pharmaceuticals LLC).

• FDA approval · 2024-11-04
  FDA Approved: LANSOPRAZOLE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved a generic version of lansoprazole via an Original Abbreviated New Drug Application for Macleods Pharmaceuticals Limited.

• FDA approval · 2024-10-23
  FDA Approved: ESOMEPRAZOLE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Esomeprazole under an Original Application for Macleods' generic product, enabling generic market access.

• 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 approval · 2024-08-20
  FDA Approved: FAMOTIDINE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved Baxter Healthcare Corporation's supplemental application for famotidine (ANDA075591), granting approval for the generic product…

• FDA approval · 2024-08-06
  FDA Approved: FAMOTIDINE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved the original ANDA application for famotidine from Novadoz Pharmaceuticals LLC, enabling a generic version of famotidine to reac…

• CLINICAL_TRIALS research · 2024-07-22
  Clinical Trial Update: Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg/10 ml Oral Suspension and Riopan 800 mg Chewable Tablets in Healthy Volunteers [NA]

  Clinical trial compares pharmacodynamics and pharmacodynamic equivalence of Antareit 800 mg/10 ml oral suspension and Riopan 800 mg chewable…

• FDA approval · 2024-07-17
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Somerset Therapeutics, LLC)

  FDA approved a supplemental application for esomeprazole magnesium by Somerset Therapeutics, LLC.

• FDA approval · 2024-07-05
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Lansoprazole from Mylan Pharmaceuticals Inc. under an existing ANDA, approving a generic version…

• FDA approval · 2024-05-28
  FDA Approved: FAMOTIDINE — Original Application (LEADER/ Cardinal Health 110, Inc.)

  FDA approved the original ANDA for famotidine from LEADER/ Cardinal Health 110, Inc., providing a generic version of famotidine.

• FDA approval · 2024-05-21
  FDA Approved: SUCRALFATE — Original Application (Strides Pharma Science Limited)

  The FDA approved Strides Pharma Science Limited's generic sucralfate under an Original Application (ANDA).

• FDA approval · 2024-05-14
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approves a supplemental application for Lansoprazole from Dr. Reddy's Laboratories Inc., authorizing changes to an existing generic prod…

• FDA approval · 2024-05-03
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for lansoprazole from Mylan Pharmaceuticals Inc., indicating an amendment to the approved generic pr…

• FDA approval · 2024-04-15
  FDA Approved: PANTOPRAZOLE SODIUM I.V. — Supplemental Application (Piramal Critical Care)

  The FDA approved a supplemental application for Pantoprazole Sodium for Injection (IV), submitted by Piramal Critical Care, enabling its con…

• FDA approval · 2024-04-05
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Edenbridge Pharmaceuticals LLC.)

  FDA approved a supplemental application for pantoprazole sodium from Edenbridge Pharmaceuticals LLC., indicating an approved modification un…

• FDA approval · 2024-03-21
  FDA Approved: SUCRALFATE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved Ingenus Pharmaceuticals' original application for sucralfate (generic formulation).

• FDA approval · 2024-02-23
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Medcore LLC)

  The FDA approved a supplemental application for Lansoprazole submitted by Medcore LLC. The snippet does not specify the exact changes covere…

• FDA approval · 2024-02-14
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Baxter Healthcare Corporation)

  FDA approved Baxter's original application for pantoprazole sodium in 0.9% sodium chloride. It is a proton pump inhibitor used to treat acid…

• FDA approval · 2024-02-14
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for lansoprazole filed by Mylan Pharmaceuticals (ANDA 090763).