Gastroesophageal Reflux Disease

• 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 · 2024-03-06
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Parenteral Medicines, Inc.)

  FDA approved Teva Parenteral Medicines, Inc.'s supplemental application for metoclopramide (ANDA073135), approving changes to the approved p…

• 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…

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• 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…

• FDA approval · 2023-12-27
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Zhejiang Yongtai Pharmaceutical Co., Ltd)

  FDA approved Esomeprazole Magnesium from Zhejiang Yongtai Pharmaceutical Co., Ltd under an Original Application (ANDA217022).

• FDA approval · 2023-12-26
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approves a supplemental application for a generic omeprazole and sodium bicarbonate product from Ajanta Pharma USA Inc.

• FDA approval · 2023-12-22
  FDA Approved: FAMOTIDINE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings, Inc.'s original ANDA for famotidine, allowing the generic version to enter the market. Famotidine is an…

• 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.

• FDA approval · 2023-12-14
  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, under NDA 020325.

• FDA approval · 2023-12-11
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved Granules Pharmaceuticals Inc.'s Pantoprazole Sodium as an original-application generic pantoprazole product.

• FDA approval · 2023-11-20
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Esomeprazole Magnesium from Aurobindo Pharma Limited, indicating regulatory approval of an a…

• FDA approval · 2023-11-20
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Wal-Mart Stores, Inc.)

  The FDA approved Wal-Mart Stores, Inc.'s supplemental application for esomeprazole magnesium, a generic proton pump inhibitor.

• FDA approval · 2023-11-15
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc)

  FDA approved a supplemental application for esomeprazole magnesium from Sun Pharmaceutical Industries, Inc. under an ANDA process, indicatin…

• FDA approval · 2023-11-14
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Camber Pharmaceuticals' generic esomeprazole magnesium. This action confirms regulatory appr…

• FDA approval · 2023-11-08
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Esomeprazole Magnesium from Zydus Pharmaceuticals USA Inc., supporting its generic approval.

• FDA approval · 2023-11-01
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Northstar Rx LLC)

  The FDA approved a supplemental application for pantoprazole sodium from Northstar Rx LLC under an ANDA, authorizing updated manufacturing/l…

• FDA approval · 2023-10-31
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Rabeprazole sodium submitted by Ascend Laboratories, LLC. This action approves the referenced ge…

• FDA approval · 2023-10-27
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Pantoprazole Sodium under an Original Application by Camber Pharmaceuticals, Inc.