Gastroesophageal Reflux Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2014-12-19FDA 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 (Pfizer). …
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FDA approval · 2014-12-19FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Dexilant (dexlansoprazole) by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2014-12-12FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)
The FDA approved Apotex Corp's supplemental application for a generic omeprazole product.
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FDA approval · 2014-12-10FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for metoclopramide from Teva Pharmaceuticals USA, Inc., authorizing changes to the product's labelin…
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FDA approval · 2014-12-10FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for Pantoprazole Sodium from Lannett Company, Inc., confirming the generic version of this product.
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FDA approval · 2014-12-05FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for pantoprazole sodium from Torrent Pharmaceuticals Limited, marking an update to the product's app…
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FDA approval · 2014-11-05FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental NDA for Protonix IV (pantoprazole sodium) from Wyeth Pharmaceuticals (Pfizer), confirming/adding the intrave…
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FDA approval · 2014-10-31FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for omeprazole from Sandoz Inc, authorizing continued manufacture and sale of a generic omeprazole p…
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FDA approval · 2014-10-31FDA Approved: OMEPRAZOLE — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's generic omeprazole, establishing bioequivalence to the reference product and authorizing its marketing in the United…
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FDA approval · 2014-10-03FDA Approved: NEXIUM 24HR CLEARMINIS — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental NDA for NEXIUM 24HR CLEARMINIS (esomeprazole magnesium) by Haleon US Holdings LLC.
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FDA approval · 2014-09-26FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approves a supplemental application for PROTONIX I.V., authorizing the intravenous form of pantoprazole sodium.
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FDA approval · 2014-09-26FDA Approved: TAGAMET — Supplemental Application (Prestige Brands Holdings, Inc.)
The FDA approved a supplemental application for Tagamet (cimetidine) filed by Prestige Brands Holdings, Inc., likely resulting in labeling c…
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FDA approval · 2014-09-10FDA Approved: PANTOPRAZOLE SODIUM — Original Application (XLCare Pharmaceuticals Inc.)
FDA approves the original abbreviated new drug application for pantoprazole sodium, enabling a generic pantoprazole product from XLCare Phar…
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FDA approval · 2014-08-05FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for pantoprazole sodium by Lannett Company, Inc. under an ANDA.
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FDA approval · 2014-05-30FDA Approved: FAMOTIDINE — Original Application (Akorn)
The FDA approved Akorn's original application for a generic famotidine product, enabling market entry of a competitor to the brand-name drug…
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FDA approval · 2014-05-15FDA Approved: PRILOSEC OTC — Supplemental Application (The Procter & Gamble Manufacturing Company)
FDA approved a supplemental application for Prilosec OTC (omeprazole magnesium) from The Procter & Gamble Manufacturing Company.
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FDA approval · 2014-02-25FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)
FDA approved a supplemental application for Prilosec (omeprazole magnesium) from Covis Pharma US, Inc. The approval updates the labeling for…
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FDA approval · 2014-02-14FDA Approved: OMEPRAZOLE MAGNESIUM — Supplemental Application (Gericare Pharmaceuticals)
FDA approved a supplemental application for Omeprazole Magnesium by Gericare Pharmaceuticals, updating the approval status for this generic …
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FDA approval · 2014-01-29FDA Approved: METOCLOPRAMIDE HYDROCHLORIDE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)
FDA approved a supplemental application for metoclopramide hydrochloride from Chartwell Governmental & Specialty RX, LLC., indicating approv…
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FDA approval · 2014-01-07FDA Approved: CIMETIDINE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for the generic drug cimetidine by Mylan Pharmaceuticals Inc.
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FDA approval · 2013-12-20FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
The FDA approved a supplemental application for the combination product Omeprazole and Sodium Bicarbonate from Oceanside Pharmaceuticals.
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FDA approval · 2013-12-20FDA Approved: METOCLOPRAMIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved a generic metoclopramide hydrochloride tablet under an original application from Heritage Pharmaceuticals (d/b/a Avet Pharmaceu…
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FDA approval · 2013-12-19FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for omeprazole from Sandoz Inc, authorizing updates to the approved generic product.
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FDA approval · 2013-12-12FDA 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 to treat gastroesophageal…
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FDA approval · 2013-12-10FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for pantoprazole sodium (generic) submitted by Lannett Company, Inc., indicating an additional regul…