Peptic Ulcer Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-07-18FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
The FDA approved Oceanside Pharmaceuticals' supplemental application for omeprazole and sodium bicarbonate, updating the product labeling ac…
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CLINICAL_TRIALS trial_result · 2023-07-14Clinical Trial Update: Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs [Phase 3]
A Phase 3 clinical trial evaluating the safety and efficacy of tegoprazan to prevent peptic ulcers in patients taking NSAIDs is ongoing with…
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FDA approval · 2023-07-03FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved the original application for a fixed-dose combination of bismuth subcitrate potassium, metronidazole, and tetracycline hydrochl…
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FDA approval · 2023-06-16FDA Approved: FAMOTIDINE — Original Application (Upsher-Smith Laboratories, LLC)
FDA approves the original Abbreviated New Drug Application for famotidine from Upsher-Smith Laboratories, LLC, granting a generic version of…
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FDA approval · 2023-05-25FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for the fixed-dose combination of chlordiazepoxide hydrochloride and clidinium bromide (Librax) …
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FDA approval · 2023-05-15FDA Approved: FAMOTIDINE — Original Application (Ascend Laboratories, LLC)
The FDA approved the original ANDA for famotidine from Ascend Laboratories, LLC, enabling a generic version of the H2 blocker to enter the m…
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FDA approval · 2023-04-27FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' supplemental application for Esomeprazole Magnesium, a generic proton pump inhibitor, marking a rou…
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FDA approval · 2023-03-08FDA Approved: ESOMEPRAZOLE SODIUM — Supplemental Application (Gland Pharma Limited)
FDA approved a supplemental application for esomeprazole sodium from Gland Pharma Limited, expanding the generic's regulatory approval. The …
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FDA approval · 2023-03-06FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Original Application (Par Health USA, LLC)
FDA approved an original ANDA for a generic fixed-dose combination of bismuth subcitrate potassium, metronidazole and tetracycline hydrochlo…
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FDA approval · 2023-02-27FDA Approved: GLYCOPYRROLATE — Original Application (Lifestar Pharma LLC)
FDA approves Lifestar Pharma LLC's original ANDA for glycopyrrolate, a generic version of the drug.
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FDA approval · 2023-01-13FDA Approved: LIBRAX — Supplemental Application (Bausch Health US, LLC)
FDA approved a supplemental application for Librax (chlordiazepoxide hydrochloride and clidinium bromide) from Bausch Health US, LLC.
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FDA approval · 2022-12-23FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for the combination drug chlordiazepoxide hydrochloride and clidinium bromide (brand name Librax) ma…
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FDA approval · 2022-09-30FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
FDA granted a supplemental approval for Good Neighbor Pharmacy Omeprazole (omeprazole) from AmerisourceBergen.
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FDA approval · 2022-08-25FDA Approved: ZANTAC 360 — Supplemental Application (Chattem, Inc.)
The FDA approved a supplemental application for ZANTAC 360 (famotidine) submitted by Chattem, Inc., under ANDA206531.
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FDA approval · 2022-08-15FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)
The FDA approved a supplemental application for pantoprazole filed by NorthStar RxLLC.
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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 · 2022-07-28FDA Approved: FAMOTIDINE — Supplemental Application (Akorn)
FDA approved a supplemental application for famotidine from Akorn (ANDA 201995). This approval confirms continued availability of this gener…
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FDA approval · 2022-07-28FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Eugia US LLC)
The FDA approved a supplemental application for pantoprazole sodium from Eugia US LLC. The action pertains to an already approved generic, t…
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FDA approval · 2022-04-15FDA Approved: SUCRALFATE — Original Application (Amneal Pharmaceuticals NY LLC)
The FDA approved Amneal Pharmaceuticals NY LLC's original ANDA for sucralfate, enabling a generic version to come to market. Sucralfate is a…
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FDA approval · 2022-04-14FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application to market a generic fixed-dose combination of lansoprazole, amoxicillin, and clarithromycin for Heli…
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FDA approval · 2022-03-04FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
The FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) by Waylis Therapeutics LLC. The snippet does not specify the ex…
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FDA approval · 2022-03-04FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for a generic omeprazole product from Lannett Company, Inc.
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FDA approval · 2022-03-04FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application for PROTONIX I.V. (pantoprazole sodium), adding an intravenous formulation under Wyeth/Pfizer to exp…
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FDA approval · 2022-03-04FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for a generic triple-drug regimen of lansoprazole, amoxicillin, and clarithromycin (manufactured by …
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FDA approval · 2022-03-04FDA Approved: OMEPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for Camber Pharmaceuticals' Omeprazole, a generic proton pump inhibitor, under the ANDA process.