Duodenal Ulcer

• 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 …

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• 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 · 2019-07-01
  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.

• FDA approval · 2019-04-25
  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) from Wyeth Pharmaceuticals (a Pfizer subsidiary).

• FDA approval · 2019-04-09
  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.

• FDA approval · 2019-04-04
  FDA Approved: NEXIUM 24HR CLEARMINIS — Supplemental Application (Haleon US Holdings LLC)

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

• CLINICAL_TRIALS trial_result · 2019-02-27
  Clinical Trial Update: Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT [Phase 2, Phase 3]

  A randomized trial update on a cytoprotective agent for preventing gastric and duodenal ulcers induced by antiplatelet therapy, with Phase 2…

• FDA approval · 2019-02-07
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for Lannett Company's generic rabeprazole sodium product.

• FDA approval · 2019-02-01
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for rabeprazole sodium (generic) submitted by Aurobindo Pharma Limited. This confirms an approve…

• FDA approval · 2019-01-31
  FDA Approved: RANITIDINE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved an original ANDA for ranitidine from Rising Pharma Holdings, Inc., enabling the marketing of a generic ranitidine product.

• FDA approval · 2019-01-18
  FDA Approved: LANSOPRAZOLE — Original Application (Medcore LLC)

  The FDA approved Lansoprazole as an original generic application (ANDA) from Medcore LLC, making a generic version available.

• FDA approval · 2018-11-30
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Rabeprazole SODIUM from Torrent Pharmaceuticals Limited.

• FDA approval · 2018-11-27
  FDA Approved: LANSOPRAZOLE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original Abbreviated New Drug Application for lansoprazole from Zydus Pharmaceuticals USA Inc., enabling a generic version …