Gastroesophageal Reflux Disease
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Sign up freeTop drugs studied for this disease
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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 · 2010-10-29FDA Approved: FAMOTIDINE — Supplemental Application (Dr.Reddy's Laboratories Limited)
The FDA approved a supplemental application for famotidine from Dr. Reddy's Laboratories Limited, authorizing a modification to an existing …
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FDA approval · 2010-10-27FDA Approved: RANITIDINE — Supplemental Application (Pharmaceutical Associates, Inc.)
The FDA approved a supplemental application for ranitidine submitted by Pharmaceutical Associates, Inc. The approval updates the product's e…
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FDA approval · 2010-09-03FDA 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 Pfizer subs…
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FDA approval · 2010-09-03FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Dexilant (dexlansoprazole) filed by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2010-09-03FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC.
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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 · 2010-09-03FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)
FDA approved a supplemental application for Prilosec (omeprazole magnesium) submitted by Covis Pharma US, Inc., representing a labeling amen…
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FDA approval · 2010-07-15FDA Approved: FAMOTIDINE — Supplemental Application (Alembic Pharmaceuticals Inc.)
FDA approved a supplemental application for famotidine from Alembic Pharmaceuticals Inc., adding approved changes to the product under the A…
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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 · 2010-07-06FDA Approved: PRILOSEC OTC — Supplemental Application (The Procter & Gamble Manufacturing Company)
The FDA approved a supplemental application to market Prilosec OTC as an over-the-counter product containing omeprazole magnesium.
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FDA approval · 2010-06-29FDA Approved: FAMOTIDINE — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' original application for famotidine, a generic H2 blocker used for ulcers and GERD indications.
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FDA approval · 2010-06-03FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Parenteral Medicines, Inc.)
FDA approved a supplemental application for metoclopramide from Teva Parenteral Medicines, Inc., updating the product's approval status as p…
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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 · 2010-04-30FDA Approved: RANITIDINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a supplemental application for ranitidine from Amneal Pharmaceuticals of New York LLC.
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FDA approval · 2010-04-15FDA Approved: ZEGERID OTC — Supplemental Application (Riley Consumer Care LLC)
The FDA approved Riley Consumer Care LLC's supplemental application for ZEGERID OTC, confirming its status as an over-the-counter omeprazole…
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FDA approval · 2010-03-31FDA Approved: METOCLOPRAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved ANI Pharmaceuticals’ supplemental application for metoclopramide, updating the regulatory status of this generic drug.
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FDA approval · 2010-03-04FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP. The approval update…
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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 · 2010-01-20FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
FDA approved a supplemental application to update the labeling for Omeprazole and Sodium Bicarbonate (Oceanside Pharmaceuticals).
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FDA approval · 2009-12-01FDA Approved: METOCLOPRAMIDE — Supplemental Application (Ipca Laboratories Limited)
FDA approved Ipca Laboratories Limited's supplemental application for Metoclopramide, granting approval of a generic version of the drug. Th…
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FDA approval · 2009-11-18FDA Approved: NIZATIDINE — Original Application (Amneal Pharmaceuticals LLC)
FDA approves Amneal's nizatidine original application (generic) for use in conditions treated by H2 blockers.
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FDA approval · 2009-11-10FDA Approved: LANSOPRAZOLE — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved an original ANDA for lansoprazole from Teva Pharmaceuticals USA, Inc., allowing a generic version of the proton pump inhibitor.…
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FDA approval · 2009-11-10FDA Approved: LANSOPRAZOLE — Original Application (Mylan Pharmaceuticals Inc.)
The FDA approved Mylan Pharmaceuticals Inc.'s Original Application for a generic lansoprazole (Lansoprazole) under ANDA090763. Lansoprazole …
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FDA approval · 2009-11-06FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Teva's metoclopramide product, updating its regulatory status as a marketed generic drug.