Gastroesophageal Reflux Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2012-12-17FDA Approved: FAMOTIDINE — Original Application (Lupin Pharmaceuticals,Inc.)
FDA approves Lupin Pharmaceuticals' famotidine as a generic product under an original ANDA, authorizing its marketing for approved indicatio…
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FDA approval · 2012-12-12FDA Approved: FAMOTIDINE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for famotidine filed by Chartwell RX, LLC.
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FDA approval · 2012-11-13FDA Approved: CIMETIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's supplemental application for cimetidine, resulting in an expanded label/approval for the drug.
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FDA approval · 2012-11-13FDA Approved: CIMETIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for cimetidine, updating the product under an existing approval.
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FDA approval · 2012-11-09FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
FDA approved Oceanside Pharmaceuticals' supplemental application for the fixed-dose combination of omeprazole and sodium bicarbonate, with u…
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FDA approval · 2012-11-02FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for omeprazole submitted by Lannett Company, Inc. The approval pertains to a change to the marketed …
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FDA approval · 2012-10-29FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
The FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole, submitted by Amerisource Bergen, for an additional use or…
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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 · 2012-10-09FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)
FDA approved a supplemental application for Prilosec (omeprazole magnesium) by Covis Pharma US, Inc, indicating an approved update to the la…
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FDA approval · 2012-10-05FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
The FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC.
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FDA approval · 2012-09-28FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Dexilant (lansoprazole) from Takeda Pharmaceuticals America, expanding its labeling and indicati…
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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: 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 · 2012-09-28FDA Approved: PANTOPRAZOLE SODIUM — Original Application (NorthStar Rx LLC)
FDA approves Pantoprazole sodium from NorthStar Rx LLC as an Original Application (ANDA), making a generic proton pump inhibitor available f…
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FDA approval · 2012-09-18FDA Approved: ZEGERID OTC — Supplemental Application (Riley Consumer Care LLC)
The FDA approved Riley Consumer Care LLC's supplemental application for ZEGERID OTC, a fixed-dose combination of omeprazole and sodium bicar…
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FDA approval · 2012-09-13FDA Approved: PRILOSEC OTC — Supplemental Application (The Procter & Gamble Manufacturing Company)
The FDA approved a supplemental application to make PRILOSEC OTC (omeprazole magnesium) available as an over-the-counter product for appropr…
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FDA approval · 2012-09-10FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
FDA approved a supplemental application for GOOD NEIGHBOR PHARMACY OMEPRAZOLE (omeprazole) under NDA 022032, with Amerisource Bergen as the …
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FDA approval · 2012-09-10FDA Approved: METOCLOPRAMIDE — Supplemental Application (Genus Lifesciences Inc.)
The FDA approved a supplemental application for metoclopramide hydrochloride from Genus Lifesciences Inc., completing regulatory action for …
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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 · 2012-08-27FDA Approved: OMEPRAZOLE MAGNESIUM — Supplemental Application (Gericare Pharmaceuticals)
FDA approved a supplemental application for Omeprazole Magnesium by Gericare Pharmaceuticals under ANDA078878, approving the changes describ…
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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 · 2012-05-18FDA Approved: BASIC CARE LANSOPRAZOLE — Original Application (Amazon.com Services LLC)
FDA approved a generic lansoprazole product, BASIC CARE LANSOPRAZOLE, under an original application by Amazon.com Services LLC. This provide…