Peptic Ulcer Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-12-02FDA Approved: SUCRALFATE — Original Application (AvPAK)
FDA approved the original ANDA for sucralfate oral, enabling generic marketing by AvPAK.
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FDA approval · 2019-11-01FDA Approved: TALICIA — Original Application (RedHill Biopharma Ltd)
FDA approved TALICIA, a fixed-dose combination of omeprazole magnesium, amoxicillin, and rifabutin, for Helicobacter pylori infection. The a…
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FDA approval · 2019-10-22FDA 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…
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FDA approval · 2019-09-24FDA 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…
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FDA approval · 2019-08-19FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Pantoprazole Sodium as an original generic application from Sun Pharmaceutical Industries, Inc.
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FDA approval · 2019-07-01FDA 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.
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FDA approval · 2019-05-10FDA 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…
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FDA approval · 2019-05-10FDA 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.
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FDA approval · 2019-04-25FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application to add intravenous pantoprazole sodium (PROTONIX I.V.) as a new dosage form for the drug, expand…
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FDA approval · 2019-04-25FDA 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).
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FDA approval · 2019-03-26FDA Approved: TAGAMET — Supplemental Application (Prestige Brands Holdings, Inc.)
FDA approved a supplemental application for Tagamet (cimetidine) from Prestige Brands Holdings, Inc., resulting in an updated product labeli…
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FDA approval · 2019-02-01FDA 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…
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FDA approval · 2018-11-05FDA Approved: OMEPRAZOLE — Original Application (BluePoint Laboratories)
FDA approved BluePoint Laboratories' original ANDA for a generic omeprazole product. Omeprazole is a proton pump inhibitor indicated for gas…
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FDA approval · 2018-10-05FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for the combination of bismuth subitrate potassium, metronidazole, and tetracycline hydrochloride (H…
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FDA approval · 2018-07-23FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc)
FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental application for Esomeprazole Magnesium. This approval authorizes the marketi…
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FDA approval · 2018-07-20FDA Approved: OMEPRAZOLE — Original Application (INNOVUS PHARMACEUTICALS, INC.)
FDA approved a generic version of omeprazole (omeprazole and omeprazole magnesium) under ANDA210593 from Innovus Pharmaceuticals.
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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 · 2018-06-07FDA Approved: OMEPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for Omeprazole by Quallent Pharmaceuticals Health LLC.
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FDA approval · 2018-06-07FDA Approved: OMEPRAZOLE — Supplemental Application (Golden State Medical Supply, Inc.)
The FDA approved a supplemental application for the generic omeprazole from Golden State Medical Supply, Inc., authorizing changes to the ap…
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FDA approval · 2018-05-31FDA Approved: OMEPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for omeprazole from Aurobindo Pharma Limited, authorizing their generic omeprazole product.
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FDA approval · 2018-04-30FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Sun Pharmaceutical Industries, Inc)
The FDA approved Sun Pharmaceutical's original application for Esomeprazole Magnesium, a proton pump inhibitor. It is used to treat gastroes…
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FDA approval · 2018-04-24FDA Approved: RABEPRAZOLE SODIUM — Original Application (Ascend Laboratories, LLC)
FDA approved Rabeprazole sodium from Ascend Laboratories, LLC as an Original Application (ANDA 208644), authorizing a generic proton pump in…
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FDA approval · 2018-04-13FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for PREVACID Solutab (lansoprazole) from Takeda Pharmaceuticals America, Inc., indicating a regu…
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FDA approval · 2018-01-25FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for a combination product containing bismuth subcitrate potassium, metronidazole, and tetracycline h…
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FDA approval · 2017-12-20FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application for PROTONIX I.V., approving its intravenous pantoprazole sodium formulation. This expands treat…