Helicobacter Pylori Infection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2016-10-14FDA Approved: LANSOPRAZOLE — Original Application (Ajanta Pharma USA Inc.)
FDA approved Ajanta Pharma USA Inc.'s generic lansoprazole under an original ANDA.
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FDA approval · 2016-10-07FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Original Application (Rising Pharma Holdings, Inc.)
FDA approved a new generic triple-therapy combination of lansoprazole, amoxicillin, and clarithromycin (Original Application) from Rising Ph…
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FDA approval · 2016-08-10FDA Approved: ESOMEPRAZOLE SODIUM — Original Application (Eugia US LLC)
FDA approved Eugia US LLC's original application for esomeprazole sodium, a generic proton pump inhibitor, confirming a generic version of t…
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FDA approval · 2016-07-25FDA Approved: IDKIT HP ONE — Supplemental Application (Meridian Bioscience Israel Ltd)
The FDA approved a supplemental application for IDKIT HP ONE, a diagnostic test kit using 13C-urea for detecting Helicobacter pylori infecti…
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FDA approval · 2016-07-25FDA Approved: LANSOPRAZOLE — Original Application (Xiromed LLC)
FDA approved the original application for a generic lansoprazole from Xiromed LLC.
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FDA approval · 2016-07-08FDA Approved: IDKIT HP ONE — Supplemental Application (Meridian Bioscience Israel Ltd)
FDA approved a supplemental application for IDKIT HP ONE, a diagnostic kit consisting of citric acid anhydrous and 13C urea, from Meridian B…
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FDA approval · 2016-06-01FDA Approved: LANSOPRAZOLE — Original Application (Rite Aid Corporation)
FDA approved an original-application generic lansoprazole (a proton pump inhibitor) as an approved product; Rite Aid Corporation was the app…
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FDA approval · 2016-02-26FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for the fixed-dose combination of bismuth subcitrate potassium, metronidazole, and tetracycline hydr…
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FDA approval · 2016-02-25FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for omeprazole from Lannett Company, Inc., effectively updating the product labeling under the ANDA.
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FDA approval · 2015-12-16FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for PREVACID (lansoprazole) submitted by Takeda Pharmaceuticals America, Inc. The approval updates t…
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FDA approval · 2015-09-28FDA Approved: CLARITHROMYCIN — Original Application (Solaris Pharma Corporation)
FDA approved an Original Application (ANDA) for Clarithromycin from Solaris Pharma Corporation, establishing a generic version of clarithrom…
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FDA approval · 2015-08-19FDA Approved: OMEPRAZOLE — Original Application (Aurobindo Pharma Limited)
The FDA approved Aurobindo Pharma Limited's original application for a generic omeprazole product.
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FDA approval · 2015-07-27FDA Approved: CLARITHROMYCIN — Supplemental Application (Chartwell RX, LLC.)
FDA approved Chartwell RX, LLC.'s supplemental application for Clarithromycin (generic) under the ANDA process, resulting in approval of a g…
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FDA approval · 2015-07-01FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for clarithromycin from Sandoz Inc, indicating continued/expanded approval for generic use of the dr…
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FDA approval · 2015-04-02FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
The FDA approved a supplemental application for rabeprazole sodium from Torrent Pharmaceuticals Limited under ANDA 202376, indicating a post…
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FDA approval · 2015-03-20FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)
FDA approved a supplemental application for omeprazole from Apotex Corp., authorizing a generic version of the drug.
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FDA approval · 2015-03-16FDA Approved: OMEPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for omeprazole submitted by Dr. Reddy's Laboratories Limited.
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FDA approval · 2015-03-06FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) submitted by AmerisourceBergen, under NDA 022032.
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FDA approval · 2015-02-25FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA has approved a supplemental application for Pantoprazole Sodium from Torrent Pharmaceuticals Limited, resulting in the approval of the g…
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FDA approval · 2014-12-19FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP.
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FDA approval · 2014-12-19FDA Approved: ESOMEPRAZOLE STRONTIUM — Supplemental Application (R2 Pharma, LLC)
FDA approved a supplemental application for esomeprazole strontium from R2 Pharma, LLC, granting approval of this salt form under NDA 202342…
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FDA approval · 2014-12-19FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for PREVACID (lansoprazole) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2014-12-12FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)
The FDA approved Apotex Corp's supplemental application for a generic omeprazole product.
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FDA approval · 2014-10-31FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for omeprazole from Sandoz Inc, authorizing continued manufacture and sale of a generic omeprazole p…
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FDA approval · 2014-10-31FDA Approved: OMEPRAZOLE — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's generic omeprazole, establishing bioequivalence to the reference product and authorizing its marketing in the United…