Gastroesophageal Reflux Disease

• FDA approval · 2025-01-17
  FDA Approved: PEPCID COMPLETE — Supplemental Application (Lil' Drug Store Products, Inc.)

  The FDA approved a supplemental application to authorize Pepcid Complete chewable tablets (famotidine with calcium carbonate and magnesium h…

• FDA approval · 2025-01-16
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved the original abbreviated new drug application for pantoprazole sodium from Rising Pharma Holdings, enabling the generic pro…

• FDA approval · 2024-12-19
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Medcore LLC)

  The FDA approved a supplemental application for lansoprazole from Medcore LLC, enabling a generic lansoprazole product to be marketed under …

• FDA approval · 2024-12-19
  FDA Approved: LANSOPRAZOLE — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for lansoprazole submitted by NorthStar Rx LLC.

• 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.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2024-11-27
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for pantoprazole sodium from Amneal Pharmaceuticals LLC, updating the approval for this generic prot…

• 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.

• 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 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…

• FDA approval · 2024-08-01
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Pantoprazole sodium from Fresenius Kabi USA as an original application (ANDA) generic product.

• 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 · 2024-05-14
  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 · 2024-04-30
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Dr. Reddy's Laboratories Inc)

  FDA approved Dr. Reddy's Laboratories' esomeprazole magnesium as a generic product under an Original Application (ANDA 207198). The approval…

• FDA approval · 2024-04-23
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for pantoprazole sodium (generic pantoprazole) from Ajanta Pharma USA Inc. under ANDA217416.

• 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…