Gastroesophageal Reflux Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2008-05-20FDA Approved: FAMOTIDINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for famotidine (Hikma Pharmaceuticals USA Inc.). The approval updates the labeling to reflect additi…
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FDA approval · 2008-04-21FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for PREVACID (lansoprazole) filed by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2008-04-21FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approves a supplemental application for PREVACID SOLUTAB (lansoprazole) filed by Takeda Pharmaceuticals America, expanding the product's…
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FDA approval · 2008-03-20FDA Approved: RANITIDINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for ranitidine from Amneal Pharmaceuticals of New York LLC, authorizing the continued marketing of a…
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FDA approval · 2008-02-29FDA 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. Thi…
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FDA approval · 2008-02-27FDA Approved: NEXIUM — Original Application (AstraZeneca Pharmaceuticals LP)
FDA approved Nexium (esomeprazole magnesium) through its Original Application, marking its original approval as a proton pump inhibitor for …
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FDA approval · 2008-02-27FDA Approved: FAMOTIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for famotidine from Teva Pharmaceuticals USA, Inc., updating the approved generic product.
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FDA approval · 2008-02-06FDA Approved: ACID REDUCER PLUS ANTACID — Original Application (CVS Pharmacy)
FDA approved the original application for ACID REDUCER PLUS ANTACID, a combination product containing famotidine with calcium carbonate and …
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FDA approval · 2007-12-21FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
FDA approved a supplemental application for the combination product omeprazole and sodium bicarbonate from Oceanside Pharmaceuticals.
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FDA approval · 2007-12-21FDA Approved: METOCLOPRAMIDE HYDROCHLORIDE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)
FDA approved a supplemental application for Metoclopramide Hydrochloride (generic) from Chartwell Governmental & Specialty RX, LLC. The acti…
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FDA approval · 2007-12-20FDA 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) from Wyeth Pharmaceuticals LLC, a subsidiary …
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FDA approval · 2007-12-20FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application to add an intravenous form of pantoprazole (PROTONIX I.V.), expanding the approved route of administ…
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FDA approval · 2007-11-14FDA Approved: PROTONIX DELAYED-RELEASE — Original Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved the original application for Pantoprazole sodium delayed-release (Protonix Delayed-Release) by Wyeth/Pfizer for the treatment o…
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FDA approval · 2007-10-22FDA Approved: OMEPRAZOLE — Original Application (Apotex Corp)
FDA approved Apotex Corp's original application for a generic omeprazole product, enabling a generic option for treating gastroesophageal re…
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FDA approval · 2007-10-22FDA Approved: OMEPRAZOLE — Original Application (Quallent Pharmaceuticals Health LLC)
FDA approved the original (ANDA) application for omeprazole from Quallent Pharmaceuticals Health LLC, authorizing a generic omeprazole produ…
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FDA approval · 2007-09-21FDA Approved: RANITIDINE — Original Application (Pharmaceutical Associates, Inc.)
FDA approved an original application for ranitidine (generic) by Pharmaceutical Associates, Inc.
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FDA approval · 2007-08-31FDA Approved: RANITIDINE — Original Application (Dr. Reddy's Laboratories Limited)
FDA approved the original ANDA for ranitidine from Dr. Reddy's Laboratories Limited, enabling a generic ranitidine product to be marketed in…
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FDA approval · 2007-04-27FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca, resulting in updated labeling.
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FDA approval · 2007-03-21FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for omeprazole by Sandoz Inc. This action updates the current approval for this generic drug.
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FDA approval · 2007-03-16FDA Approved: CIMETIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for cimetidine, approving changes to its labeling/indication. This update broadens or clarifies…
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FDA approval · 2006-10-20FDA Approved: NEXIUM — Original Application (AstraZeneca Pharmaceuticals LP)
FDA approved Nexium (esomeprazole magnesium) as AstraZeneca's original NDA. The approval established Nexium as a proton pump inhibitor for a…
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FDA approval · 2006-10-13FDA Approved: RANITIDINE — Original Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved Amneal Pharmaceuticals of New York LLC's original application for generic ranitidine, authorizing its commercial ranitidine…
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FDA approval · 2006-09-26FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for omeprazole from Lannett Company, Inc., enabling the marketing of the generic omeprazole product.
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FDA approval · 2006-09-25FDA Approved: FAMOTIDINE — Original Application (Chain Drug Consortium, LLC)
The FDA approved Chain Drug Consortium, LLC's original application for famotidine, enabling a generic version of famotidine to be marketed. …
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FDA approval · 2006-09-25FDA Approved: ACID RELIEF — Original Application (Rite Aid Corporation)
The FDA approved ACID RELIEF (famotidine) from Rite Aid under an Original Application (ANDA), making a generic famotidine product available.