Helicobacter Pylori Infection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2014-10-28FDA Approved: IDKIT HP ONE — Supplemental Application (Meridian Bioscience Israel Ltd)
FDA approved a supplemental application for IDKIT HP ONE, a diagnostic test kit using citric acid anhydrous and 13C urea, developed by Merid…
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FDA approval · 2014-05-28FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for the combination drug bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride,…
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FDA approval · 2014-02-25FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)
FDA approved a supplemental application for Prilosec (omeprazole magnesium) from Covis Pharma US, Inc. The approval updates the labeling for…
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FDA approval · 2014-02-05FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride, a combination therap…
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FDA approval · 2013-12-19FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for omeprazole from Sandoz Inc, authorizing updates to the approved generic product.
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FDA approval · 2013-11-08FDA Approved: RABEPRAZOLE SODIUM — Original Application (Torrent Pharmaceuticals Limited)
FDA approves Torrent Pharmaceuticals Limited's original application for generic rabeprazole sodium, a proton pump inhibitor indicated for ga…
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FDA approval · 2013-10-31FDA Approved: OMEPRAZOLE MAGNESIUM — Supplemental Application (Gericare Pharmaceuticals)
The FDA approved a supplemental application for omeprazole magnesium from Gericare Pharmaceuticals, granting approval for a generic product …
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FDA approval · 2013-08-27FDA Approved: LANSOPRAZOLE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Lansoprazole from Mylan Pharmaceuticals Inc., resulting in approval of a generic Lansoprazol…
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FDA approval · 2013-08-14FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental NDA for a bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride product (NDA 050786) from …
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FDA approval · 2013-08-06FDA Approved: ESOMEPRAZOLE STRONTIUM — Original Application (R2 Pharma, LLC)
FDA approved esomeprazole strontium via the Original Application (NDA202342) for indications consistent with proton pump inhibitors (GERD-re…
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FDA approval · 2013-01-23FDA 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 · 2013-01-18FDA Approved: IDKIT HP ONE — Supplemental Application (Meridian Bioscience Israel Ltd)
FDA approved a supplemental application for IDKIT HP ONE by Meridian Bioscience Israel Ltd, enabling expanded labeling for the Helicobacter …
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FDA approval · 2012-11-02FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for omeprazole submitted by Lannett Company, Inc. The approval pertains to a change to the marketed …
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FDA approval · 2012-10-09FDA 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 · 2012-10-09FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)
FDA approved a supplemental application for Prilosec (omeprazole magnesium) by Covis Pharma US, Inc, indicating an approved update to the la…
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FDA approval · 2012-09-28FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca Pharmaceuticals LP.
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FDA approval · 2012-09-28FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Prevacid Solutab (lansoprazole) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2012-07-25FDA Approved: CLARITHROMYCIN — Original Application (Rising Pharma Holdings, Inc.)
FDA approved a generic clarithromycin product under an original ANDA from Rising Pharma Holdings, Inc.
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FDA approval · 2012-05-18FDA Approved: BASIC CARE LANSOPRAZOLE — Original Application (Amazon.com Services LLC)
FDA approved a generic lansoprazole product, BASIC CARE LANSOPRAZOLE, under an original application by Amazon.com Services LLC. This provide…
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FDA approval · 2012-05-18FDA Approved: LANSOPRAZOLE — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approved the original ANDA for lansoprazole from Dr. Reddy's Laboratories, authorizing a generic lansoprazole product.
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FDA approval · 2012-05-11FDA 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).
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FDA approval · 2012-05-08FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
The FDA approved Waylis Therapeutics LLC's supplemental application for ACIPHEX (rabeprazole sodium).
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FDA approval · 2012-04-18FDA Approved: LANSOPRAZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for lansoprazole, authorizing the marketing of a generic lansoprazole…
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FDA approval · 2012-04-16FDA Approved: LANSOPRAZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for Lansoprazole from Teva Pharmaceuticals USA, Inc. The submission concerns a supplemental chan…
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FDA approval · 2012-03-23FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)
FDA approves Apotex Corp's supplemental application for omeprazole (generic) under ANDA076048. This authorizes the marketing of a generic om…