Gastric Ulcers
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-12-10FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for esomeprazole magnesium from Ascend Laboratories, LLC, under an approved ANDA.
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FDA approval · 2024-11-22FDA Approved: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approved Ajanta Pharma USA Inc.'s supplemental application for Naproxen and Esomeprazole Magnesium (ANDA 213699), establishing a generic…
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CLINICAL_TRIALS trial_result · 2024-07-29Clinical Trial Update: Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection [Phase 4]
A Phase 4 clinical trial update comparing Vonorasan to Esomeprazole for healing gastric ulcers after endoscopic submucosal dissection, focus…
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FDA approval · 2024-03-05FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Eugia US LLC)
FDA approved a supplemental application for pantoprazole sodium submitted by Eugia US LLC.
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FDA approval · 2024-02-01FDA Approved: METHSCOPOLAMINE BROMIDE — Original Application (i3 Pharmaceuticals, LLC)
FDA approved the original application for methscopolamine bromide, a generic anticholinergic agent, filed by i3 Pharmaceuticals, LLC.
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FDA approval · 2023-12-20FDA 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.
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FDA approval · 2023-10-18FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals' original application for esomeprazole magnesium, a proton pump inhibitor, as a generic drug. It is in…
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FDA approval · 2023-06-16FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Edenbridge Pharmaceuticals LLC.)
FDA approves Edenbridge Pharmaceuticals' pantoprazole sodium generic under an Original Application (ANDA).
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FDA approval · 2022-10-17FDA Approved: MISOPROSTOL — Original Application (Micro Labs Limited)
The FDA approved an original application for a generic misoprostol product from Micro Labs Limited.
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FDA approval · 2022-08-04FDA Approved: FAMOTIDINE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approves Amneal's original application for famotidine, enabling a generic version of the H2 blocker. The approval covers common indicati…
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FDA approval · 2022-05-19FDA Approved: PANTOPRAZOLE SODIUM I.V. — Original Application (Piramal Critical Care)
FDA approved Pantoprazole sodium for injection (IV) from Piramal Critical Care under an original application.
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FDA approval · 2022-02-18FDA 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.
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FDA approval · 2020-02-18FDA Approved: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM — Original Application (Dr. Reddy's Laboratories Limited)
FDA approved Dr. Reddy's Laboratories Limited for Naproxen and Esomeprazole Magnesium under an Original Application (ANDA) for a generic Nap…
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FDA approval · 2019-11-14FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)
FDA approved a Supplemental Application for Pantoprazole from NorthStar RxLLC, indicating an approved revision or addition to this generic p…
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FDA approval · 2018-06-07FDA Approved: PROTONIX DELAYED-RELEASE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application for PROTONIX DELAYED-RELEASE (pantoprazole sodium) submitted by Wyeth Pharmaceuticals LLC (Pfize…
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FDA approval · 2017-02-07FDA Approved: RANITIDINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for ranitidine from Amneal Pharmaceuticals of New York LLC (ANDA 077824).
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FDA label_change · 2016-12-19FDA Approved: CYTOTEC — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for Cytotec (misoprostol) from Pfizer Laboratories Div Pfizer Inc, resulting in a labeling update.
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FDA approval · 2016-04-22FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for Esomeprazole Magnesium (generic esomeprazole magnesium) submitted by NorthStar Rx LLC.
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CLINICAL_TRIALS trial_result · 2014-05-08Clinical Trial Update: Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID) [Phase 3]
Phase 3 long-term extension study evaluating TAK-438 (vonoprazan) for preventing recurrent gastric or duodenal ulcers in patients on NSAIDs;…
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CLINICAL_TRIALS trial_result · 2014-05-08Clinical Trial Update: Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin [Phase 3]
TAK-438 (tegoprazan) was evaluated in a long-term extension Phase 3 trial to prevent recurrent gastric or duodenal ulcers in patients on low…
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FDA approval · 2012-09-28FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application to add an intravenous formulation of pantoprazole (PROTONIX I.V.) from Wyeth Pharmaceuticals (Pf…
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FDA approval · 2012-01-20FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP.
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CLINICAL_TRIALS trial_result · 2011-01-25Clinical Trial Update: Ulcer Prevention II [Phase 3]
Phase 3 clinical trial update for prevention of NSAID-associated gastric ulcers; the study has completed.
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FDA approval · 2010-01-31FDA Approved: RANITIDINE — Supplemental Application (Pharmaceutical Associates, Inc.)
The FDA approved a supplemental application for ranitidine filed by Pharmaceutical Associates, Inc., updating the drug's labeling. This acti…
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FDA approval · 2009-08-31FDA Approved: RANITIDINE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for ranitidine by Dr. Reddy's Laboratories Limited.