Peptic Ulcer Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2012-10-09FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP.
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FDA approval · 2012-10-09FDA 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 modify/expand its labeling.
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FDA approval · 2012-09-28FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca Pharmaceuticals LP.
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FDA approval · 2012-09-28FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Prevacid Solutab (lansoprazole) submitted by Takeda Pharmaceuticals America, Inc.
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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 · 2012-09-07FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Pantoprazole sodium from Mylan Pharmaceuticals Inc., continuing approval for this generic produc…
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FDA approval · 2012-06-13FDA Approved: FAMOTIDINE — Supplemental Application (Carlsbad Technology, Inc)
FDA approved a supplemental application for famotidine from Carlsbad Technology, Inc.
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FDA approval · 2011-12-07FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
FDA approved a supplemental application for Oceanside Pharmaceuticals' omeprazole and sodium bicarbonate, updating labeling through a supple…
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FDA approval · 2011-12-07FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application to authorize the intravenous form of Protonix (pantoprazole sodium) from Wyeth Pharmaceuticals (Pfiz…
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FDA approval · 2011-12-06FDA Approved: METHSCOPOLAMINE BROMIDE — Original Application (Breckenridge Pharmaceutical, Inc.)
FDA approved a generic methscopolamine bromide product in an Original Application for Breckenridge Pharmaceutical, Inc.
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FDA approval · 2011-01-19FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Torrent Pharmaceuticals Limited)
FDA approved Pantoprazole sodium from Torrent Pharmaceuticals Limited under an original ANDA; a generic version of pantoprazole for conditio…
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FDA approval · 2011-01-19FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved the original ANDA for pantoprazole sodium, a generic proton pump inhibitor manufactured by Mylan Pharmaceuticals. This approval…
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FDA approval · 2011-01-06FDA Approved: FAMOTIDINE — Supplemental Application (Baxter Healthcare Corporation)
FDA approved a supplemental application for famotidine submitted by Baxter Healthcare Corporation, resulting in a label change for the produ…
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FDA approval · 2010-12-22FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for clarithromycin by Sandoz Inc., confirming the approval of a generic clarithromycin product under…
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FDA approval · 2010-11-23FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for Omeprazole from Sandoz Inc, granting approval for this generic proton pump inhibitor under an AN…
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FDA approval · 2010-11-17FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for the generic omeprazole from Lannett Company, Inc., authorizing continued marketing under the…
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FDA approval · 2010-09-03FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
The FDA approved Oceanside Pharmaceuticals' supplemental application for Omeprazole and Sodium Bicarbonate.
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FDA approval · 2010-07-15FDA Approved: FAMOTIDINE — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved Dr. Reddy's Laboratories Limited's supplemental application for famotidine.
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FDA approval · 2010-05-27FDA Approved: FAMOTIDINE — Original Application (Navinta LLC)
FDA approves Navinta LLC's original application for famotidine. This approval permits a generic version of famotidine to enter the market.
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FDA approval · 2010-02-26FDA Approved: IDKIT HP ONE — Supplemental Application (Meridian Bioscience Israel Ltd)
FDA Supplemental Application approval for IDKIT HP ONE, a 13C-urea citric acid breath test kit for detecting Helicobacter pylori infection.
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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 · 2009-07-31FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for PREVACID SOLUTAB (lansoprazole) to add the Solutab dosage form to the approved product line. The…
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FDA approval · 2009-02-27FDA Approved: CIMETIDINE 200 ACID REDUCER — Supplemental Application (Walgreen Company)
FDA approved a supplemental application to approve Walgreens' Cimetidine 200 Acid Reducer as a generic cimetidine product.
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FDA approval · 2008-11-24FDA Approved: ACID CONTROLLER — Supplemental Application (H E B)
FDA approved a supplemental application for ACID CONTROLLER (famotidine) from H E B. The approval expands the product's labeling/indications…
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FDA approval · 2008-09-12FDA Approved: SUCRALFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for sucralfate by Teva Pharmaceuticals USA, Inc., marking an approved modification to the generic pr…