Gastroesophageal Reflux Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-10-18FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals' original application for esomeprazole magnesium, a proton pump inhibitor, as a generic drug. It is in…
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FDA approval · 2023-10-11FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for Omeprazole from Sandoz Inc, granting regulatory approval for changes to the generic product'…
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FDA approval · 2023-10-11FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
FDA approved a Supplemental Application for omeprazole by Sandoz Inc, confirming approval of a supplement to the Abbreviated New Drug Applic…
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FDA approval · 2023-10-05FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Pantoprazole Sodium from Camber Pharmaceuticals, Inc. under ANDA213778.
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FDA approval · 2023-10-05FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Esomeprazole Magnesium from Mylan Pharmaceuticals, making a generic version of the proton pump i…
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FDA approval · 2023-09-29FDA Approved: ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG — Original Application (MARKSANS PHARMA LIMITED)
FDA approved Marksans Pharma Limited's esomeprazole magnesium delayed-release capsules, 20 mg, as a generic therapeutic option for common ac…
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FDA approval · 2023-09-27FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)
FDA approved a supplemental application for pantoprazole by NorthStar RxLLC under ANDA077619.
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FDA approval · 2023-09-27FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for pantoprazole sodium by Lannett Company, Inc., approving changes to the product's labeling relate…
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FDA approval · 2023-09-27FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
The FDA approved a supplemental application for Pantoprazole Sodium from Torrent Pharmaceuticals Limited.
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FDA approval · 2023-09-26FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for Pantoprazole sodium from NorthStar Rx LLC.
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FDA approval · 2023-09-18FDA Approved: PANTOPRAZOLE SODIUM DELAYED-RELEASE — Supplemental Application (Lifestar Pharma LLC)
FDA approved a supplemental application for Pantoprazole Sodium Delayed-Release from Lifestar Pharma LLC, approving a new generic pantoprazo…
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FDA approval · 2023-09-18FDA Approved: FAMOTIDINE — Original Application (Ajanta Pharma USA Inc.)
FDA approved Ajanta Pharma USA Inc.'s original ANDA for famotidine, a generic version of the histamine-2 blocker.
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FDA approval · 2023-09-14FDA Approved: FAMOTIDINE — Original Application (Micro Labs Limited)
FDA approved Micro Labs Limited's original ANDA for famotidine. This approval allows the marketing of a generic famotidine product.
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FDA approval · 2023-09-11FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Cipla USA Inc.)
FDA approved a supplemental application for esomeprazole magnesium submitted by Cipla USA Inc.
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FDA approval · 2023-09-11FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Novadoz Pharmaceuticals LLC)
The FDA approved a supplemental application for pantoprazole sodium filed by Novadoz Pharmaceuticals LLC. This action updates the product la…
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FDA approval · 2023-08-17FDA Approved: FAMOTIDINE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' original application for famotidine, a generic H2 blocker used to treat ulcers and gastroesophageal ref…
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FDA approval · 2023-08-08FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for PREVACID SOLUTAB to include the lansoprazole Solutab formulation from Takeda Pharmaceuticals Ame…
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FDA approval · 2023-08-02FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Eugia US LLC)
FDA approved a supplemental application for pantoprazole sodium from Eugia US LLC, adding a regulatory change to an existing pantoprazole pr…
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FDA approval · 2023-07-18FDA 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 (Pfizer). This act…
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FDA approval · 2023-07-18FDA 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 · 2023-07-18FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Dexilant (dexlansoprazole) filed by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's supplemental application for omeprazole (generic), granting changes to the approved ANDA product labeling.
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FDA approval · 2023-07-18FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Civica, Inc.)
FDA approved a supplemental application for pantoprazole sodium by Civica, Inc., likely involving labeling or indication changes.
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FDA approval · 2023-07-18FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
The FDA approved Oceanside Pharmaceuticals' supplemental application for omeprazole and sodium bicarbonate, updating the product labeling ac…
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FDA approval · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for omeprazole by Aurobindo Pharma Limited. The action provides regulatory clearance for the generic…