Gastroesophageal Reflux Disease

• FDA approval · 2021-07-26
  FDA Tentative Approval: PANTOPRAZOLE SODIUM — Supplemental Application (Civica, Inc.)

  The FDA issued tentative approval for Civica, Inc.'s pantoprazole sodium supplemental application (NDA 209463), enabling tentative U.S. mark…

• FDA approval · 2021-07-20
  FDA Approved: FAMOTIDINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for famotidine from Dr. Reddy's Laboratories Limited.

• FDA approval · 2021-07-07
  FDA Approved: BERKLEY AND JENSEN OMEPRAZOLE — Supplemental Application (BJWC)

  FDA approved a supplemental application for Berkley and Jensen Omeprazole (omeprazole). This approval supports updates to labeling and expan…

• FDA approval · 2021-06-04
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Pantoprazole Sodium (Sun Pharmaceutical Industries, Inc.), resulting in updated labeling for…

• FDA approval · 2021-04-20
  FDA Approved: FAMOTIDINE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' Original Application for famotidine, a generic H2 blocker, enabling marketing for ulcers and gastroeso…

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• FDA approval · 2021-03-19
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Biocon Pharma Inc.,)

  FDA approved Biocon Pharma's Original Application for esomeprazole magnesium, a generic proton pump inhibitor, enabling marketing of a lower…

• FDA approval · 2021-02-19
  FDA Approved: FAMOTIDINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for famotidine submitted by Chartwell RX, LLC (ANDA 075786). It authorizes changes to the approved g…

• FDA approval · 2021-02-01
  FDA Approved: LANSOPRAZOLE — Original Application (NorthStar Rx LLC)

  FDA approved NorthStar Rx LLC's Original Application for a generic lansoprazole. Lansoprazole is a proton pump inhibitor used to treat pepti…

• FDA approval · 2020-12-10
  FDA Approved: OMEPRAZOLE — Original Application (Golden State Medical Supply, Inc.)

  FDA approved the original application for a generic omeprazole product (ANDA 212977) manufactured by Golden State Medical Supply, Inc.

• FDA approval · 2020-12-09
  FDA Approved: OMEPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Omeprazole from Dr. Reddy's Laboratories Limited.

• FDA approval · 2020-12-04
  FDA Approved: NEXIUM 24HR CLEARMINIS — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for NEXIUM 24HR CLEARMINIS (esomeprazole magnesium) by Haleon US Holdings LLC. The approval concerns…

• FDA approval · 2020-12-01
  FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for generic omeprazole from Lannett Company under ANDA075410, authorizing continued marketing under …

• FDA approval · 2020-11-27
  FDA Approved: PROTONIX DELAYED-RELEASE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Protonix delayed-release (pantoprazole sodium) submitted by Wyeth Pharmaceuticals LLC, a subsidi…

• FDA approval · 2020-11-27
  FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for PREVACID (lansoprazole) from Takeda Pharmaceuticals America, Inc.

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for Omeprazole from Quallent Pharmaceuticals Health LLC (a generic proton pump inhibitor).

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)

  FDA approved Apotex Corp's supplemental application for omeprazole (generic), under ANDA076048.

• FDA approval · 2020-11-27
  FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Dexilant (dexlansoprazole) by Takeda Pharmaceuticals America, Inc., related to a labeling/indica…

• FDA approval · 2020-11-27
  FDA Approved: ESOMEPRAZOLE STRONTIUM — Supplemental Application (R2 Pharma, LLC)

  The FDA approved a supplemental application for esomeprazole strontium from R2 Pharma, LLC. This action authorizes the salt form of esomepra…

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for omeprazole from Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved the supplemental application for omeprazole submitted by Aurobindo Pharma Limited (ANDA 203270), granting approval for a generi…

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Omeprazole from Sandoz Inc (ANDA075757). The approval confirms the generic product under the app…

• FDA approval · 2020-11-27
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for Pantoprazole Sodium from Civica, Inc. (AP submission).

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Camber Pharmaceuticals' generic omeprazole.

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for omeprazole from Zydus Lifesciences Limited, authorizing a generic omeprazole product. The ap…

• FDA approval · 2020-11-20
  FDA Approved: EQUATE LANSOPRAZOLE — Supplemental Application (Wal-Mart Stores Inc)

  FDA approved a supplemental application for EQUATE LANSOPRAZOLE (lansoprazole) from Wal-Mart Stores Inc.