Gastritis

• FDA approval · 2025-12-10
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' original application for a generic omeprazole and sodium bicarbonate combination product.

• FDA approval · 2025-07-16
  FDA Approved: FAMOTIDINE — Original Application (Sagent Pharmaceuticals)

  FDA approved the original application for famotidine from Sagent Pharmaceuticals, marking the approval of a generic product.

• FDA approval · 2025-07-09
  FDA Approved: FAMOTIDINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original abbreviated new drug application (ANDA) for famotidine from Aurobindo Pharma Limited, a generic version of famotid…

• FDA approval · 2025-03-31
  FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)

  The FDA approved a supplemental application for the fixed-dose combination of bismuth subcitrate potassium, metronidazole, and tetracycline …

• 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 …

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• 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.

• FDA approval · 2024-07-08
  FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental application for the antibiotic combination Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochl…

• FDA approval · 2024-07-08
  FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Original Application (Winder Laboratories LLC)

  FDA approved a generic version of the combination drug chlordiazepoxide hydrochloride and clidinium bromide from Winder Laboratories LLC. Th…

• 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 · 2024-01-17
  FDA Approved: SUCRALFATE — Original Application (TruPharma, LLC)

  FDA approves the original application for sucralfate oral by TruPharma, LLC.

• FDA approval · 2023-09-14
  FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic formulation of chlordiazepoxide hydrochloride and clidinium bromide from Aurobindo Pharma Limited under an Original A…

• FDA approval · 2023-07-18
  FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA granted supplemental approval for a lansoprazole-amoxicillin-clarithromycin combination product by Rising Pharma Holdings, Inc. to e…

• FDA approval · 2023-05-25
  FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for the fixed-dose combination of chlordiazepoxide hydrochloride and clidinium bromide (Librax) …

• FDA approval · 2022-12-23
  FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for the combination drug chlordiazepoxide hydrochloride and clidinium bromide (brand name Librax) ma…

• FDA approval · 2022-07-28
  FDA Approved: CURIST ACID RELIEF — Supplemental Application (Little Pharma, Inc.)

  FDA granted a supplemental approval for Curist Acid Relief containing famotidine 20 mg from Little Pharma, Inc., updating the ANDA with the …

• 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 · 2022-01-07
  FDA Approved: FAMOTIDINE — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' original application for famotidine, establishing a new generic entry for the acid-reducing medication…

• FDA approval · 2020-06-23
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Civica, Inc.)

  The FDA approved a supplemental application for pantoprazole sodium submitted by Civica, Inc. with this action representing an approved supp…

• FDA approval · 2020-03-23
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s original application for esomeprazole magnesium, a generic proton pump inhibitor.

• FDA approval · 2020-02-21
  FDA Approved: CIMETIDINE 200 ACID REDUCER — Supplemental Application (Walgreen Company)

  The FDA approved a supplemental application for Walgreens' CIMETIDINE 200 ACID REDUCER, indicating approval of changes to the approved gener…

• FDA approval · 2019-08-07
  FDA Approved: RANITIDINE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for ranitidine submitted by Rising Pharma Holdings, Inc., indicating an approved change to the p…

• FDA approval · 2017-08-15
  FDA Approved: CARAFATE — Supplemental Application (Allergan, Inc.)

  The FDA approved Allergan's supplemental application for CARAFATE (sucralfate). This approval updates the product's labeling and/or indicati…

• FDA approval · 2013-05-30
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for pantoprazole sodium submitted by Torrent Pharmaceuticals Limited (generic pantoprazole) under an…

• FDA approval · 2013-02-22
  FDA Approved: FAMOTIDINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for famotidine submitted by Alembic Pharmaceuticals Inc.

• FDA approval · 2013-02-11
  FDA Approved: NIZATIDINE — Supplemental Application (Epic Pharma, LLC)

  FDA approved Epic Pharma, LLC's supplemental application to market a generic nizatidine product (an H2 receptor blocker) under an ANDA, expa…