Peptic Ulcer Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2017-08-18FDA Approved: KIRKLAND SIGNATURE ESOMEPRAZOLE MAGNESIUM — Original Application (Costco Wholesale Company)
The FDA approved the original generic application for Kirkland Signature Esomeprazole Magnesium, a generic version of esomeprazole magnesium…
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FDA approval · 2017-08-15FDA Approved: CARAFATE — Supplemental Application (Allergan, Inc.)
The FDA approved Allergan's supplemental application for CARAFATE (sucralfate). This approval updates the product's labeling and/or indicati…
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FDA approval · 2017-07-06FDA 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/Pfizer to update the drug's labeling.
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FDA approval · 2017-07-06FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application to authorize the intravenous formulation of Protonix (pantoprazole sodium) for specified indicat…
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FDA approval · 2017-06-30FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Civica, Inc.)
The FDA approved Civica, Inc.'s pantoprazole sodium original application (NDA 209463), a proton pump inhibitor for acid-related conditions a…
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FDA approval · 2017-06-26FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (XLCare Pharmaceuticals Inc.)
FDA approved a supplemental application for pantoprazole sodium by XLCare Pharmaceuticals Inc., validating continued approval of their panto…
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FDA approval · 2017-06-23FDA Approved: GLYCOPYRROLATE — Original Application (Somerset Therapeutics, LLC)
FDA approved the original application for a generic glycopyrrolate product from Somerset Therapeutics, LLC.
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FDA approval · 2017-05-30FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
The FDA approved a supplemental application for the combination drug Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochlor…
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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 approval · 2017-01-25FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for the fixed-dose combination of bismuth subcitrate potassium, metronidazole, and tetracycline hydr…
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FDA approval · 2016-10-07FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Original Application (Rising Pharma Holdings, Inc.)
FDA approved a new generic triple-therapy combination of lansoprazole, amoxicillin, and clarithromycin (Original Application) from Rising Ph…
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FDA approval · 2016-08-10FDA Approved: ESOMEPRAZOLE SODIUM — Original Application (Eugia US LLC)
FDA approved Eugia US LLC's original application for esomeprazole sodium, a generic proton pump inhibitor, confirming a generic version of t…
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FDA approval · 2016-08-01FDA 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, updating the product labeling as p…
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FDA approval · 2016-06-06FDA Approved: CARAFATE — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for CARAFATE (sucralfate) submitted by Allergan, Inc.
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FDA approval · 2016-05-09FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for diclofenac sodium and misoprostol from Mylan Pharmaceuticals Inc., marking an approved chang…
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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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FDA approval · 2016-04-04FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for Pantoprazole Sodium from NorthStar Rx LLC under ANDA202038.
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FDA approval · 2016-02-26FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for the fixed-dose combination of bismuth subcitrate potassium, metronidazole, and tetracycline hydr…
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FDA approval · 2016-02-03FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)
FDA approved a supplemental application for Prilosec (omeprazole magnesium) submitted by Covis Pharma US, Inc. The approval pertains to a mo…
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FDA approval · 2015-12-16FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application to add PREVACID SOLUTAB (lansoprazole) as a soluble tablet formulation. This expands the approve…
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FDA approval · 2015-10-30FDA Approved: SUCRALFATE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for sucralfate from Chartwell RX, LLC under an ANDA. The action represents an update to the approved…
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FDA approval · 2015-08-27FDA Approved: SUCRALFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for sucralfate from Teva Pharmaceuticals USA, Inc., indicating approval of a change to an existi…
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FDA approval · 2015-08-19FDA Approved: OMEPRAZOLE — Original Application (Aurobindo Pharma Limited)
The FDA approved Aurobindo Pharma Limited's original application for a generic omeprazole product.
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FDA approval · 2015-08-03FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved an original application for Esomeprazole Magnesium from Mylan as a generic proton pump inhibitor. The approval makes a generic …
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FDA approval · 2015-05-06FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)
FDA approved a supplemental application for Pepcid AC Maximum Strength (famotidine) submitted by Kenvue Brands LLC. This action expands the …