Helicobacter Pylori Infection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-09-11FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Cipla USA Inc.)
FDA approved a supplemental application for esomeprazole magnesium submitted by Cipla USA Inc.
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FDA approval · 2023-08-16FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)
FDA approved Sandoz Inc's supplemental application for clarithromycin, marking a supplemental approval for this generic antibiotic. The acti…
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FDA approval · 2023-08-16FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for a combination tablet containing lansoprazole, amoxicillin, and clarithromycin (Rising Pharma Hol…
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FDA approval · 2023-08-16FDA Approved: CLARITHROMYCIN — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for a generic version of clarithromycin produced by Lannett Company, Inc.
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FDA approval · 2023-08-16FDA Approved: VOQUEZNA DUAL PAK — Supplemental Application (Phathom Pharmaceuticals Inc.)
The FDA approved a supplemental application for Voquezna Dual Pak (vonoprazan fumarate and amoxicillin) from Phathom Pharmaceuticals.
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FDA approval · 2023-08-16FDA Approved: VOQUEZNA TRIPLE PAK — Supplemental Application (Phathom Pharmaceuticals Inc.)
FDA approves a supplemental application for Voquezna Triple Pak (vonoprazan, amoxicillin, and clarithromycin) from Phathom Pharmaceuticals.
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FDA approval · 2023-08-08FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for PREVACID SOLUTAB to include the lansoprazole Solutab formulation from Takeda Pharmaceuticals Ame…
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FDA approval · 2023-07-18FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC.
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FDA approval · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's supplemental application for omeprazole (generic), granting changes to the approved ANDA product labeling.
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FDA approval · 2023-07-18FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA granted supplemental approval for a lansoprazole-amoxicillin-clarithromycin combination product by Rising Pharma Holdings, Inc. to e…
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FDA approval · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for omeprazole by Aurobindo Pharma Limited. The action provides regulatory clearance for the generic…
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FDA approval · 2023-07-12FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Aurohealth LLC)
FDA approved esomeprazole magnesium as a generic drug from Aurohealth LLC under ANDA 214473.
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FDA approval · 2023-07-03FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved the original application for a fixed-dose combination of bismuth subcitrate potassium, metronidazole, and tetracycline hydrochl…
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FDA approval · 2023-06-07FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approved the original application for esomeprazole magnesium (generic) from Zydus Pharmaceuticals USA Inc. The approval covers the same …
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FDA approval · 2023-05-22FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc)
FDA approved Sun Pharmaceutical Industries' supplemental application for esomeprazole magnesium (generic), a proton pump inhibitor, under th…
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FDA approval · 2023-04-28FDA Approved: OMEPRAZOLE — Original Application (Aurohealth LLC)
FDA approved Aurohealth LLC's original ANDA for omeprazole, enabling the marketing of a generic proton pump inhibitor in the United States. …
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FDA approval · 2023-03-28FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Solco Healthcare US LLC)
FDA approves esomeprazole magnesium under an Original Application for Solco Healthcare US LLC, enabling a generic version of the proton pump…
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FDA approval · 2023-03-06FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Original Application (Par Health USA, LLC)
FDA approved an original ANDA for a generic fixed-dose combination of bismuth subcitrate potassium, metronidazole and tetracycline hydrochlo…
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FDA approval · 2022-09-14FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Rabeprazole sodium submitted by Aurobindo Pharma Limited.
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FDA approval · 2022-09-14FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for rabeprazole sodium (Ascend Laboratories, LLC). This indicates regulatory approval of the generic…
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FDA approval · 2022-08-29FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Northstar Rx LLC)
FDA approved Pantoprazole sodium as an original ANDA for a generic product manufactured by Northstar Rx LLC.
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FDA approval · 2022-06-24FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the original ANDA for esomeprazole magnesium as a generic proton pump inhibitor manufactured by Rising Pharma Holdings, Inc.
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FDA approval · 2022-05-03FDA Approved: VOQUEZNA DUAL PAK — Original Application (Phathom Pharmaceuticals Inc.)
FDA approved Voquezna Dual Pak (vonoprazan fumarate and amoxicillin) from Phathom Pharmaceuticals for eradication of Helicobacter pylori inf…
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FDA approval · 2022-05-03FDA Approved: VOQUEZNA TRIPLE PAK — Original Application (Phathom Pharmaceuticals Inc.)
The FDA approved Voquezna Triple Pak, a combination therapy of vonoprazan fumarate, amoxicillin, and clarithromycin, for the treatment of He…
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FDA approval · 2022-04-14FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application to market a generic fixed-dose combination of lansoprazole, amoxicillin, and clarithromycin for Heli…