Duodenal Ulcer
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Sign up freeTop drugs studied for this disease
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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 · 2018-10-05FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for the combination of bismuth subitrate potassium, metronidazole, and tetracycline hydrochloride (H…
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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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CLINICAL_TRIALS trial_result · 2018-07-10Clinical Trial Update: Efficacy of Low Dose of Proton Pump Inhibitor in Treatment Bleeding Ulcers
This completed trial evaluated the efficacy of a low-dose proton pump inhibitor for the treatment of bleeding ulcers, including marginal ulc…
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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: 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: 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: ESOMEPRAZOLE STRONTIUM — Supplemental Application (R2 Pharma, LLC)
The FDA approved a supplemental application for Esomeprazole Strontium submitted by R2 Pharma, LLC under NDA202342.
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FDA approval · 2018-06-07FDA Approved: OMEPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application (ANDA 203270) for Omeprazole from Aurobindo Pharma Limited, authorizing changes to an approved gener…
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FDA approval · 2018-06-07FDA Approved: OMEPRAZOLE — Supplemental Application (Golden State Medical Supply, Inc.)
The FDA approved a supplemental application for the generic omeprazole from Golden State Medical Supply, Inc., authorizing changes to the ap…
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FDA approval · 2018-06-07FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for the generic Omeprazole from Lannett Company, Inc., granting continued approval for this prod…
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FDA approval · 2018-05-31FDA Approved: OMEPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for omeprazole from Aurobindo Pharma Limited, authorizing their generic omeprazole product.
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FDA approval · 2018-05-31FDA Approved: OMEPRAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved Glenmark's supplemental application for omeprazole, granting approval for the generic proton pump inhibitor product. This a…
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FDA approval · 2018-05-31FDA Approved: OMEPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for omeprazole from Dr. Reddy's Laboratories Limited under the ANDA pathway.
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FDA approval · 2018-04-30FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Sun Pharmaceutical Industries, Inc)
The FDA approved Sun Pharmaceutical's original application for Esomeprazole Magnesium, a proton pump inhibitor. It is used to treat gastroes…
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FDA approval · 2018-04-24FDA Approved: RABEPRAZOLE SODIUM — Original Application (Ascend Laboratories, LLC)
FDA approved Rabeprazole sodium from Ascend Laboratories, LLC as an Original Application (ANDA 208644), authorizing a generic proton pump in…
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FDA approval · 2018-04-13FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for PREVACID Solutab (lansoprazole) from Takeda Pharmaceuticals America, Inc., indicating a regu…
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FDA approval · 2018-01-25FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for a combination product containing bismuth subcitrate potassium, metronidazole, and tetracycline h…
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FDA approval · 2018-01-24FDA Approved: NEXIUM 24HR CLEARMINIS — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for NEXIUM 24HR CLEARMINIS (esomeprazole magnesium) submitted by Haleon US Holdings LLC. The action …
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FDA approval · 2018-01-09FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) filed by Waylis Therapeutics LLC.
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FDA approval · 2017-11-30FDA Approved: EQUATE LANSOPRAZOLE — Supplemental Application (Wal-Mart Stores Inc)
The FDA approved a supplemental application for Equate Lansoprazole, Wal-Mart's store-brand lansoprazole.