Gastric Ulcer

• FDA approval · 2016-10-24
  FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC.

• FDA approval · 2016-10-24
  FDA Approved: ESOMEPRAZOLE STRONTIUM — Supplemental Application (R2 Pharma, LLC)

  The FDA approved a supplemental application to authorize the marketing of esomeprazole strontium, a salt form of esomeprazole, for use in th…

• FDA approval · 2016-10-14
  FDA Approved: LANSOPRAZOLE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s generic lansoprazole under an original ANDA.

• FDA approval · 2016-08-01
  FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for PEPCID AC MAXIMUM STRENGTH (famotidine) by Kenvue Brands LLC, updating the product labeling as p…

• FDA approval · 2016-07-25
  FDA Approved: LANSOPRAZOLE — Original Application (Xiromed LLC)

  FDA approved the original application for a generic lansoprazole from Xiromed LLC.

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• FDA approval · 2016-07-15
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Original Application (Ajanta Pharma USA Inc.)

  FDA approves Ajanta Pharma USA Inc.'s original-application generic combination of omeprazole and sodium bicarbonate for acid-related disorde…

• FDA approval · 2016-07-15
  FDA Approved: EQUATE OMEPRAZOLE AND SODIUM BICARBONATE — Original Application (WALMART INC.)

  FDA approved the original ANDA for Equate Omeprazole and Sodium Bicarbonate (Walmart Inc.), a store-brand combination proton pump inhibitor …

• FDA approval · 2016-06-07
  FDA Approved: EQUATE LANSOPRAZOLE — Original Application (Wal-Mart Stores Inc)

  FDA approves Equate Lansoprazole (Wal-Mart Stores Inc) under an Original Application for lansoprazole.

• FDA approval · 2016-06-06
  FDA Approved: CARAFATE — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for CARAFATE (sucralfate) submitted by Allergan, Inc.

• FDA approval · 2016-06-01
  FDA Approved: LANSOPRAZOLE — Original Application (Rite Aid Corporation)

  FDA approved an original-application generic lansoprazole (a proton pump inhibitor) as an approved product; Rite Aid Corporation was the app…

• FDA approval · 2016-05-05
  FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Pepcid AC Maximum Strength (famotidine) submitted by Kenvue Brands LLC. The approval pertains to…

• FDA approval · 2016-04-21
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for esomeprazole magnesium from Aurobindo Pharma Limited, making a generic version of this proton pump…

• FDA approval · 2016-03-30
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Eugia US LLC)

  The FDA approved Pantoprazole sodium from Eugia US LLC under an original ANDA, making a generic pantoprazole product available. It is indica…

• FDA approval · 2016-03-18
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (XLCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for Pantoprazole Sodium from XLCare Pharmaceuticals Inc., approving a change to this generic product…

• FDA approval · 2016-02-25
  FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for omeprazole from Lannett Company, Inc., effectively updating the product labeling under the ANDA.

• FDA approval · 2016-02-10
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  FDA approved a supplemental application to authorize Good Neighbor Pharmacy Omeprazole (omeprazole) as a store-brand proton pump inhibitor m…

• FDA approval · 2016-02-03
  FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for Prilosec (omeprazole magnesium) submitted by Covis Pharma US, Inc. The approval pertains to a mo…

• FDA approval · 2016-01-26
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' original application for pantoprazole sodium, a generic pantoprazole product, expanding access to a pro…

• FDA approval · 2015-12-22
  FDA Approved: FAMOTIDINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for famotidine from Aurobindo Pharma Limited, enabling a generic version of famotidine to be marketed.

• FDA approval · 2015-12-16
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application to add PREVACID SOLUTAB (lansoprazole) as a soluble tablet formulation. This expands the approve…

• FDA approval · 2015-12-16
  FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for PREVACID (lansoprazole) submitted by Takeda Pharmaceuticals America, Inc. The approval updates t…

• FDA approval · 2015-10-30
  FDA Approved: SUCRALFATE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for sucralfate from Chartwell RX, LLC under an ANDA. The action represents an update to the approved…

• FDA approval · 2015-09-25
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (NorthStar Rx LLC)

  FDA approved the original application for esomeprazole magnesium from NorthStar Rx LLC, a generic version of the proton pump inhibitor esome…

• FDA approval · 2015-08-27
  FDA Approved: SUCRALFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for sucralfate from Teva Pharmaceuticals USA, Inc., indicating approval of a change to an existi…

• FDA approval · 2015-08-19
  FDA Approved: OMEPRAZOLE — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for a generic omeprazole product.