Duodenal Ulcer
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-09-11FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Novadoz Pharmaceuticals LLC)
The FDA approved a supplemental application for pantoprazole sodium filed by Novadoz Pharmaceuticals LLC. This action updates the product la…
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FDA approval · 2023-08-17FDA Approved: FAMOTIDINE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' original application for famotidine, a generic H2 blocker used to treat ulcers and gastroesophageal ref…
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FDA approval · 2023-08-16FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for a combination tablet containing lansoprazole, amoxicillin, and clarithromycin (Rising Pharma Hol…
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FDA approval · 2023-08-08FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for PREVACID SOLUTAB to include the lansoprazole Solutab formulation from Takeda Pharmaceuticals Ame…
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FDA approval · 2023-08-02FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Eugia US LLC)
FDA approved a supplemental application for pantoprazole sodium from Eugia US LLC, adding a regulatory change to an existing pantoprazole pr…
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FDA approval · 2023-07-18FDA 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) from Wyeth Pharmaceuticals (Pfizer). This act…
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FDA approval · 2023-07-18FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC.
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FDA approval · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's supplemental application for omeprazole (generic), granting changes to the approved ANDA product labeling.
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FDA approval · 2023-07-18FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA granted supplemental approval for a lansoprazole-amoxicillin-clarithromycin combination product by Rising Pharma Holdings, Inc. to e…
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FDA approval · 2023-07-18FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Civica, Inc.)
FDA approved a supplemental application for pantoprazole sodium by Civica, Inc., likely involving labeling or indication changes.
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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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FDA label_change · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' supplemental application for omeprazole, resulting in updated labeling for the product. This is a s…
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FDA approval · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for omeprazole by Aurobindo Pharma Limited. The action provides regulatory clearance for the generic…
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FDA approval · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Golden State Medical Supply, Inc.)
FDA approved a supplemental application for the generic drug omeprazole from Golden State Medical Supply, Inc.
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FDA approval · 2023-07-12FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Aurohealth LLC)
FDA approved esomeprazole magnesium as a generic drug from Aurohealth LLC under ANDA 214473.
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FDA approval · 2023-07-07FDA Approved: FAMOTIDINE — Original Application (Biocon Pharma Inc.)
FDA approved Biocon Pharma Inc.'s original ANDA for famotidine, enabling a generic version of the H2 blocker for the treatment and preventio…
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FDA approval · 2023-06-30FDA Approved: LANSOPRAZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for lansoprazole from Teva Pharmaceuticals USA, Inc., updating/expanding the approval for the generi…
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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 · 2023-06-07FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approved the original application for esomeprazole magnesium (generic) from Zydus Pharmaceuticals USA Inc. The approval covers the same …
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FDA approval · 2023-05-22FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc)
FDA approved Sun Pharmaceutical Industries' supplemental application for esomeprazole magnesium (generic), a proton pump inhibitor, under th…
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FDA approval · 2023-05-22FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved Ascend Laboratories' supplemental application for esomeprazole magnesium delayed-release capsules (generic esomeprazole mag…
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FDA approval · 2023-04-28FDA Approved: OMEPRAZOLE — Original Application (Aurohealth LLC)
FDA approved Aurohealth LLC's original ANDA for omeprazole, enabling the marketing of a generic proton pump inhibitor in the United States. …
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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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CLINICAL_TRIALS trial_result · 2023-04-25Clinical Trial Update: Efficacy and Safety of LXI-15028 Comparing With Lansoprazole in the Treatment of Duodenal Ulcer [Phase 3]
A Phase 3 trial comparing LXI-15028 with lansoprazole for duodenal ulcer has completed, evaluating efficacy and safety.
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FDA approval · 2023-04-06FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for pantoprazole sodium from Mylan Pharmaceuticals Inc., granting approval of a generic pantopra…