Gastroesophageal Reflux Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-04-04FDA Approved: PRILOSEC OTC — Supplemental Application (The Procter & Gamble Manufacturing Company)
FDA approves a supplemental application for Prilosec OTC (omeprazole magnesium) submitted by The Procter & Gamble Manufacturing Company.
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FDA approval · 2019-04-04FDA Approved: NEXIUM 24HR CLEARMINIS — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for NEXIUM 24HR CLEARMINIS (esomeprazole magnesium) filed by Haleon US Holdings LLC.
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FDA approval · 2019-04-04FDA Approved: NEXIUM 24HR — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for NEXIUM 24HR (esomeprazole magnesium) by Haleon US Holdings LLC, adding a 24-hour formulation to …
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FDA approval · 2019-03-26FDA Approved: TAGAMET — Supplemental Application (Prestige Brands Holdings, Inc.)
FDA approved a supplemental application for Tagamet (cimetidine) from Prestige Brands Holdings, Inc., resulting in an updated product labeli…
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FDA approval · 2019-02-07FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for Lannett Company's generic rabeprazole sodium product.
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FDA approval · 2019-02-01FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for rabeprazole sodium (generic) submitted by Aurobindo Pharma Limited. This confirms an approve…
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FDA approval · 2019-01-31FDA Approved: RANITIDINE — Original Application (Rising Pharma Holdings, Inc.)
The FDA approved an original ANDA for ranitidine from Rising Pharma Holdings, Inc., enabling the marketing of a generic ranitidine product.
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FDA approval · 2019-01-18FDA Approved: LANSOPRAZOLE — Original Application (Medcore LLC)
The FDA approved Lansoprazole as an original generic application (ANDA) from Medcore LLC, making a generic version available.
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FDA approval · 2019-01-15FDA Approved: ZEGERID OTC — Supplemental Application (Riley Consumer Care LLC)
The FDA approved a supplemental application for ZEGERID OTC (omeprazole and sodium bicarbonate) submitted by Riley Consumer Care LLC.
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FDA approval · 2018-12-21FDA Approved: PEPCID COMPLETE — Supplemental Application (Lil' Drug Store Products, Inc.)
FDA approved a supplemental application for Pepcid Complete, a chewable tablet that combines famotidine with calcium carbonate and magnesium…
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FDA approval · 2018-11-30FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Rabeprazole SODIUM from Torrent Pharmaceuticals Limited.
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FDA approval · 2018-11-27FDA Approved: LANSOPRAZOLE — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approved the original Abbreviated New Drug Application for lansoprazole from Zydus Pharmaceuticals USA Inc., enabling a generic version …
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FDA approval · 2018-11-05FDA Approved: OMEPRAZOLE — Original Application (BluePoint Laboratories)
FDA approved BluePoint Laboratories' original ANDA for a generic omeprazole product. Omeprazole is a proton pump inhibitor indicated for gas…
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FDA approval · 2018-09-27FDA Approved: RANITIDINE — Original Application (Ajanta Pharma USA Inc.)
FDA approved Ajanta Pharma USA Inc.'s Original Application for ranitidine, a generic H2 blocker, with label indications including treatment …
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FDA approval · 2018-08-20FDA Approved: RANITIDINE — Original Application (Granules India Ltd)
FDA approved Granules India Ltd's original application for ranitidine (generic). The product is intended for conditions such as duodenal and…
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FDA approval · 2018-07-23FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc)
FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental application for Esomeprazole Magnesium. This approval authorizes the marketi…
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FDA approval · 2018-07-20FDA Approved: OMEPRAZOLE — Original Application (INNOVUS PHARMACEUTICALS, INC.)
FDA approved a generic version of omeprazole (omeprazole and omeprazole magnesium) under ANDA210593 from Innovus Pharmaceuticals.
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FDA approval · 2018-06-12FDA Approved: BERKLEY AND JENSEN OMEPRAZOLE — Supplemental Application (BJWC)
FDA approved a supplemental application for BERKLEY AND JENSEN OMEPRAZOLE (omeprazole) submitted by BJWC.
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FDA approval · 2018-06-07FDA 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) submitted by Wyeth Pharmaceuticals LLC (Pfize…
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FDA approval · 2018-06-07FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for PREVACID (lansoprazole) filed by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2018-06-07FDA Approved: OMEPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for Omeprazole by Quallent Pharmaceuticals Health LLC.
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FDA approval · 2018-06-07FDA 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) submitted by Wyeth Pharmaceuticals LLC (Pfize…
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FDA approval · 2018-06-07FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for omeprazole from Sandoz Inc, enabling the continued marketing of the generic omeprazole produ…
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FDA approval · 2018-06-07FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Dexilant (dexlansoprazole) submitted by Takeda Pharmaceuticals America, expanding its labeling t…
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FDA approval · 2018-06-07FDA Approved: ESOMEPRAZOLE STRONTIUM — Supplemental Application (R2 Pharma, LLC)
The FDA approved a supplemental application for Esomeprazole Strontium submitted by R2 Pharma, LLC under NDA202342.