Gastroesophageal Reflux Disease
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2025-04-25FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Eugia US LLC)
FDA approved a supplemental application for pantoprazole sodium by Eugia US LLC, resulting in a labeling update for the product.
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FDA label_change · 2025-02-11FDA Approved: PEPCID COMPLETE — Supplemental Application (Lil' Drug Store Products, Inc.)
The FDA approved a supplemental application for Pepcid Complete, a chewable tablet combining famotidine with calcium carbonate and magnesium…
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FDA label_change · 2025-01-31FDA Approved: PEPCID COMPLETE — Supplemental Application (Lil' Drug Store Products, Inc.)
FDA approved a supplemental application for Pepcid Complete chewable tablets (famotidine with calcium carbonate and magnesium hydroxide) sub…
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FDA label_change · 2024-09-16FDA Approved: LANSOPRAZOLE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for lansoprazole from Zydus Pharmaceuticals USA Inc., resulting in updated labeling for the prod…
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FDA label_change · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' supplemental application for omeprazole, resulting in updated labeling for the product. This is a s…
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FDA label_change · 2022-09-27FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for pantoprazole sodium from Sun Pharmaceutical Industries, resulting in an updated labeling for the…
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FDA label_change · 2022-03-04FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca Pharmaceuticals LP.
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FDA label_change · 2020-11-27FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP to update the labeli…
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FDA label_change · 2020-05-13FDA Approved: FAMOTIDINE — Supplemental Application (Carlsbad Technology, Inc)
FDA approved a supplemental application for famotidine (Carlsbad Technology, Inc.), resulting in changes to its labeling.
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FDA label_change · 2020-01-07FDA Approved: FAMOTIDINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA notes a supplemental application for famotidine by Lupin Pharmaceuticals, likely involving labeling changes for the drug.
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FDA label_change · 2016-07-08FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Dexilant (dexlansoprazole) submitted by Takeda Pharmaceuticals America, Inc. The approval ma…
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FDA label_change · 2015-12-16FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA supplemental application submission for Dexilant (dexlansoprazole) by Takeda Pharmaceuticals America, Inc., potentially seeking an updat…
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FDA label_change · 2015-03-16FDA Approved: LANSOPRAZOLE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for lansoprazole submitted by Mylan Pharmaceuticals, indicating a change to the product labeling/aut…
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FDA label_change · 2014-10-15FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC to update the labeling.
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FDA label_change · 2014-02-25FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca, resulting in changes to the product la…
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FDA label_change · 2013-12-10FDA 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) to update the product labeling. The sponsor is Wy…
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FDA label_change · 2013-09-13FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
The FDA lists a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) from AmerisourceBergen, typically related to lab…
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FDA label_change · 2012-12-20FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Dexilant (lansoprazole) filed by Takeda, extending its labeling with additional indications.
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FDA label_change · 2012-05-18FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for Pantoprazole Sodium (Lannett Company) under ANDA 078281, signaling changes to the labeling f…
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FDA label_change · 2011-06-17FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Dexilant (dexlansoprazole) submitted by Takeda, resulting in changes to the drug’s labeling.
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FDA label_change · 2011-05-20FDA 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 update the product labeling.
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FDA label_change · 2011-05-20FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC to update the product labeling…
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FDA label_change · 2010-07-16FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
The FDA approved a labeling supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) from AmerisourceBergen. The update m…
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FDA label_change · 2009-05-28FDA Approved: RANITIDINE — Supplemental Application (Pharmaceutical Associates, Inc.)
The FDA approved a supplemental application for ranitidine from Pharmaceutical Associates, Inc., indicating a labeling or related change to …
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FDA label_change · 2007-01-24FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for metoclopramide from Teva Pharmaceuticals USA, Inc., resulting in changes to the product labe…