Gastroesophageal Reflux Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-05-18FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' pantoprazole sodium as an original ANDA generic product. It is indicated for GERD-related conditions su…
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FDA approval · 2022-05-03FDA Approved: DEXLANSOPRAZOLE — Supplemental Application (ENDO USA, Inc.)
The FDA approved a supplemental application for a generic Dexlansoprazole from ENDO USA, Inc., enabling market availability.
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FDA approval · 2022-03-04FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
The FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) by Waylis Therapeutics LLC. The snippet does not specify the ex…
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FDA approval · 2022-03-04FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approves a supplemental application for PREVACID SOLUTAB (lansoprazole) from Takeda Pharmaceuticals America, Inc.
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FDA approval · 2022-03-04FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)
FDA approved a supplemental application for Omeprazole submitted by Apotex Corp.
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FDA approval · 2022-03-04FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Dexilant (dexlansoprazole) from Takeda Pharmaceuticals America, expanding or modifying its l…
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FDA approval · 2022-03-04FDA Approved: OMEPRAZOLE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for omeprazole submitted by Zydus Lifesciences Limited. The exact scope of the supplement (such as l…
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FDA approval · 2022-03-04FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for a generic omeprazole product from Lannett Company, Inc.
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FDA approval · 2022-03-04FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application for PROTONIX I.V. (pantoprazole sodium), adding an intravenous formulation under Wyeth/Pfizer to exp…
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FDA approval · 2022-03-04FDA Approved: OMEPRAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved Glenmark's supplemental application for omeprazole, a generic proton pump inhibitor, expanding or updating its approval for…
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FDA approval · 2022-03-04FDA Approved: OMEPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for Camber Pharmaceuticals' Omeprazole, a generic proton pump inhibitor, under the ANDA process.
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FDA approval · 2022-02-28FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)
The FDA approved a supplemental application for omeprazole from Apotex Corp, supporting a new generic entry for the product.
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FDA approval · 2022-02-18FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)
The FDA approved a supplemental application for PEPCID AC MAXIMUM STRENGTH (famotidine) from Kenvue Brands LLC.
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FDA approval · 2022-01-28FDA Approved: CURIST ACID RELIEF — Original Application (Little Pharma, Inc.)
The FDA approved CURIST ACID RELIEF, a 20 mg famotidine tablet from Little Pharma, Inc., under an original ANDA.
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FDA approval · 2022-01-07FDA Approved: FAMOTIDINE — Original Application (Ascend Laboratories, LLC)
The FDA approved Ascend Laboratories' original application for famotidine, establishing a new generic entry for the acid-reducing medication…
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FDA approval · 2021-11-14FDA Approved: LANSOPRAZOLE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for lansoprazole from Zydus Pharmaceuticals USA Inc.
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FDA approval · 2021-11-12FDA Approved: LANSOPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Camber Pharmaceuticals' lansoprazole, a generic proton pump inhibitor, under ANDA 203083.
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FDA approval · 2021-11-09FDA Approved: LANSOPRAZOLE — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approves Ajanta Pharma USA Inc.'s supplemental application for lansoprazole (generic). This action approves a generic Lansoprazole produ…
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FDA approval · 2021-11-03FDA Approved: FAMOTIDINE — Original Application (Ascent Pharmaceuticals, Inc.)
The FDA approves the original generic application for famotidine by Ascent Pharmaceuticals, Inc., enabling a generic version of this H2 bloc…
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FDA approval · 2021-10-21FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) manufactured by AmerisourceBergen.
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FDA approval · 2021-10-15FDA Approved: LANSOPRAZOLE — Supplemental Application (Dr.Reddy's Laboratories Ltd.)
The FDA approved a supplemental application for lansoprazole by Dr. Reddy's Laboratories Ltd. This approval updates the current marketing au…
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FDA approval · 2021-10-15FDA Approved: FAMOTIDINE — Original Application (XLCare Pharmaceuticals, Inc.)
FDA approved an original application for famotidine from XLCare Pharmaceuticals, Inc., marking the approval of a generic famotidine product.
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FDA approval · 2021-09-14FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for rabeprazole sodium (generic) from Ascend Laboratories, LLC.
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FDA approval · 2021-08-30FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for a generic rabeprazole sodium product from Aurobindo Pharma Limited.
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FDA approval · 2021-08-25FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP. The approval up…