Gastric Ulcer

• FDA approval · 2020-04-30
  FDA Approved: OMEPRAZOLE, SODIUM BICARBONATE — Original Application (Guardian Drug Company)

  FDA approved Guardian Drug Company's original application for omeprazole sodium bicarbonate, a generic proton pump inhibitor combination, fo…

• FDA approval · 2020-04-01
  FDA Approved: ESOMEPRAZOLE SODIUM — Original Application (Gland Pharma Limited)

  FDA approved the original application for esomeprazole sodium (generic) from Gland Pharma Limited, enabling its marketing in the United Stat…

• FDA approval · 2020-03-25
  FDA Approved: OMEPRAZOLE — Original Application (CHAIN DRUG MARKETING ASSOCIATION, INC.)

  The FDA approves an original application for omeprazole (generic) submitted by Chain Drug Marketing Association, Inc., covering indications …

• FDA approval · 2020-03-23
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s original application for esomeprazole magnesium, a generic proton pump inhibitor.

• FDA approval · 2020-03-23
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s Esomeprazole Magnesium as a generic version of esomeprazole under an Original Application (ANDA).

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• FDA approval · 2020-03-03
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Lifestar Pharma LLC.)

  FDA approves a supplemental application to allow Lifestar Pharma LLC to market a generic version of lansoprazole.

• FDA approval · 2020-02-21
  FDA Approved: CIMETIDINE 200 ACID REDUCER — Supplemental Application (Walgreen Company)

  The FDA approved a supplemental application for Walgreens' CIMETIDINE 200 ACID REDUCER, indicating approval of changes to the approved gener…

• FDA approval · 2020-01-03
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for pantoprazole sodium from Lannett Company (ANDA 078281).

• FDA approval · 2019-12-02
  FDA Approved: SUCRALFATE — Original Application (AvPAK)

  FDA approved the original ANDA for sucralfate oral, enabling generic marketing by AvPAK.

• FDA approval · 2019-11-29
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Advagen Pharma Limited)

  FDA approved a supplemental application for Rabeprazole sodium by Advagen Pharma Limited.

• FDA approval · 2019-11-15
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves a supplemental application for Rabeprazole sodium from Amneal Pharmaceuticals LLC (ANDA 204179).

• FDA approval · 2019-11-14
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for pantoprazole sodium from Torrent Pharmaceuticals Limited.

• FDA approval · 2019-10-22
  FDA Approved: ACID CONTROLLER — Supplemental Application (H E B)

  The FDA approved a supplemental application for ACID CONTROLLER (famotidine) submitted by H E B.

• FDA approval · 2019-10-22
  FDA Approved: FAMOTIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for famotidine from Teva Pharmaceuticals USA, Inc., indicating changes or additions to the approved …

• FDA approval · 2019-10-22
  FDA Approved: FAMOTIDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for famotidine by Aurobindo Pharma Limited under an ANDA, extending approval to include this manufac…

• FDA approval · 2019-09-26
  FDA Approved: OMEPRAZOLE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' generic omeprazole in an Original Abbreviated New Drug Application, authorizing its use for the same in…

• FDA approval · 2019-09-24
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for OMEPRAZOLE AND SODIUM BICARBONATE (omeprazole and sodium bicarbonate) from Oceanside Pharmaceuti…

• FDA approval · 2019-09-16
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for pantoprazole sodium from Amneal Pharmaceuticals LLC.

• FDA approval · 2019-09-11
  FDA Approved: ZANTAC 360 — Supplemental Application (Chattem, Inc.)

  The FDA approved a supplemental application for ZANTAC 360 (famotidine) from Chattem, Inc., updating the product under an approved supplemen…

• FDA approval · 2019-08-07
  FDA Approved: RANITIDINE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for ranitidine submitted by Rising Pharma Holdings, Inc., indicating an approved change to the p…

• FDA approval · 2019-07-02
  FDA Approved: MISOPROSTOL — Original Application (AvPAK)

  FDA approved a generic version of misoprostol under AvPAK's original ANDA, for prevention of NSAID-induced gastric ulcers.

• FDA approval · 2019-07-01
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for lansoprazole from Teva Pharmaceuticals USA, Inc. for the generic product under the ANDA process.

• FDA approval · 2019-05-10
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's original generic application for esomeprazole magnesium, authorizing its use as a proton pump inhibitor. The pro…

• FDA approval · 2019-05-10
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Dr.Reddy's Laboratories Ltd.)

  The FDA approved a supplemental application for Lansoprazole from Dr. Reddy's Laboratories Ltd., approving the generic product update.

• FDA approval · 2019-05-03
  FDA Approved: OMEPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for omeprazole from Aurobindo Pharma Limited under ANDA203270.