Helicobacter Pylori Infection
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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 · 2018-07-23FDA 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: 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 (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 (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 · 2018-01-25FDA 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 · 2017-10-30FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
The FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole), with AmerisourceBergen as the manufacturer, …
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FDA approval · 2017-10-18FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Prevacid Solutab (lansoprazole) by Takeda Pharmaceuticals America, Inc., related to the Solu…
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FDA approval · 2017-09-28FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for omeprazole by Sandoz Inc (ANDA 076515).
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FDA approval · 2017-09-21FDA Approved: LANSOPRAZOLE — Original Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's original ANDA for lansoprazole, enabling a generic version to be marketed for acid-related disorders.
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FDA approval · 2017-08-18FDA Approved: KIRKLAND SIGNATURE ESOMEPRAZOLE MAGNESIUM — Original Application (Costco Wholesale Company)
The FDA approved the original generic application for Kirkland Signature Esomeprazole Magnesium, a generic version of esomeprazole magnesium…
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FDA approval · 2017-07-06FDA Approved: PROTONIX DELAYED-RELEASE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application for Protonix Delayed-Release (pantoprazole sodium) from Wyeth/Pfizer to update the drug's labeling.
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FDA approval · 2017-07-05FDA Approved: BERKLEY AND JENSEN OMEPRAZOLE — Original Application (BJWC)
FDA approved Berkley and Jensen Omeprazole under an original application; the product is a proton pump inhibitor indicated for gastroesophag…
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FDA approval · 2017-05-30FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
The FDA approved a supplemental application for the combination drug Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochlor…
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FDA approval · 2017-02-17FDA Approved: RABEPRAZOLE SODIUM — Original Application (Aurobindo Pharma Limited)
FDA approved an original ANDA for a generic rabeprazole sodium product from Aurobindo Pharma Limited.
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FDA approval · 2017-01-25FDA 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 · 2017-01-19FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
The FDA approved a supplemental application for the Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride product from …
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FDA approval · 2016-12-01FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
The FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) from AmerisourceBergen, updating labeling and…
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FDA approval · 2016-10-24FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
The FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC.
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FDA approval · 2016-10-24FDA Approved: ESOMEPRAZOLE STRONTIUM — Supplemental Application (R2 Pharma, LLC)
The FDA approved a supplemental application to authorize the marketing of esomeprazole strontium, a salt form of esomeprazole, for use in th…