Erosive Esophagitis

• 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 · 2024-11-04
  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…

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• 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…

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

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

• FDA approval · 2024-02-23
  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).

• FDA approval · 2024-02-05
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Esomeprazole Magnesium submitted by Zydus Pharmaceuticals USA Inc., enabling the generic esomepr…

• FDA approval · 2024-01-19
  FDA Approved: DEXLANSOPRAZOLE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approval of Mylan's original ANDA for dexlansoprazole, providing a generic version of the proton pump inhibitor to treat acid-related di…

• FDA approval · 2024-01-16
  FDA Approved: FAMOTIDINE — Original Application (DR. REDDY'S LABORATORIES INC)

  The FDA approved the original ANDA for famotidine from Dr. Reddy's Laboratories, authorizing a generic version of famotidine. This is a rout…

• FDA approval · 2024-01-11
  FDA Approved: OMEPRAZOLE SODIUM BICARBONATE — Supplemental Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s supplemental application for omeprazole sodium bicarbonate (ANDA 207476), confirming its marketing approva…

• FDA approval · 2024-01-10
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Biocon Pharma Inc.,)

  The FDA approved Biocon Pharma Inc.'s supplemental application for Esomeprazole Magnesium, a generic esomeprazole product, under ANDA 213486…