Gastroesophageal Reflux Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2011-10-28FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for PREVACID SOLUTAB (lansoprazole) submitted by Takeda Pharmaceuticals America, Inc. The action…
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FDA approval · 2011-10-28FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Dexilant (dexlansoprazole) by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2011-08-29FDA 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 to support O…
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FDA approval · 2011-07-31FDA Approved: NIZATIDINE — Supplemental Application (Epic Pharma, LLC)
FDA approved a supplemental application for nizatidine from Epic Pharma, LLC (ANDA 076178). This marks approval of a supplemental update for…
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FDA approval · 2011-07-25FDA Approved: ZEGERID OTC — Supplemental Application (Riley Consumer Care LLC)
FDA approved a supplemental application for ZEGERID OTC from Riley Consumer Care LLC to update/expand its OTC labeling for the omeprazole so…
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FDA approval · 2011-07-22FDA Approved: PRILOSEC OTC — Supplemental Application (The Procter & Gamble Manufacturing Company)
The FDA approved a supplemental application for PRILOSEC OTC (omeprazole magnesium) from The Procter & Gamble Manufacturing Company.
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FDA approval · 2011-06-20FDA Approved: PRILOSEC OTC — Supplemental Application (The Procter & Gamble Manufacturing Company)
The FDA approved a supplemental application for Prilosec OTC (omeprazole magnesium) submitted by The Procter & Gamble Manufacturing Company.
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FDA approval · 2011-06-16FDA Approved: PRILOSEC OTC — Supplemental Application (The Procter & Gamble Manufacturing Company)
FDA approved a supplemental application for PRILOSEC OTC (omeprazole magnesium) by The Procter & Gamble Manufacturing Company.
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FDA approval · 2011-06-07FDA 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) from Wyeth Pharmaceut…
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FDA approval · 2011-06-01FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for PREVACID SOLUTAB (lansoprazole) to add a Solutab formulation, submitted by Takeda Pharmaceut…
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FDA approval · 2011-05-20FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application to add the intravenous formulation of PROTONIX (pantoprazole sodium) from Wyeth Pharmaceuticals …
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FDA approval · 2011-05-20FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
FDA approved a supplemental application for Omeprazole and Sodium Bicarbonate from Oceanside Pharmaceuticals, updating the labeling to refle…
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FDA approval · 2011-05-20FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Dexilant (dexlansoprazole) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2011-04-07FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Dexilant (lansoprazole) from Takeda Pharmaceuticals America, Inc., updating its labeling to …
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FDA approval · 2011-02-28FDA Approved: METOCLOPRAMIDE — Supplemental Application (Genus Lifesciences Inc.)
FDA approved Genus Lifesciences' supplemental application for metoclopramide hydrochloride (metoclopramide), authorizing its generic product…
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FDA approval · 2011-02-25FDA Approved: PRILOSEC OTC — Supplemental Application (The Procter & Gamble Manufacturing Company)
The FDA approved a supplemental application for Prilosec OTC (omeprazole magnesium) to support its over‑the‑counter labeling and use. This a…
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FDA approval · 2011-01-20FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Lannett Company, Inc.)
FDA approved Lannett Company's original Abbreviated New Drug Application for pantoprazole sodium, enabling a generic pantoprazole product. T…
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FDA approval · 2011-01-19FDA Approved: PANTOPRAZOLE — Original Application (NorthStar RxLLC)
FDA approved the original application for pantoprazole submitted by NorthStar RxLLC, launching a generic pantoprazole product.
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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 · 2011-01-07FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for omeprazole from Sandoz Inc., granting an additional approval under the ANDA for the generic …
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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 · 2010-12-20FDA Approved: PRILOSEC OTC — Supplemental Application (The Procter & Gamble Manufacturing Company)
FDA approved a supplemental application for PRILOSEC OTC (omeprazole magnesium) submitted by The Procter & Gamble Manufacturing Company.
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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 · 2010-11-18FDA Approved: REGLAN — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for REGLAN (metoclopramide hydrochloride) from ANI Pharmaceuticals, representing an approved regulat…