Urinary Tract Infection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-12-01FDA Approved: METHENAMINE HIPPURATE — Original Application (Jubilant Cadista Pharmaceuticals Inc.)
FDA approved Jubilant Cadista Pharmaceuticals Inc.'s original application for methenamine hippurate, a urinary tract antiseptic, for the pre…
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FDA approval · 2023-11-03FDA Approved: NITROFURANTOIN — Original Application (Micro Labs Limited)
FDA approves the original application for Nitrofurantoin from Micro Labs Limited as a generic drug.
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FDA approval · 2023-08-08FDA Approved: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for nitrofurantoin monohydrate/macrocrystals filed by Sandoz Inc.
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FDA approval · 2023-07-11FDA Approved: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) — Original Application (NorthStar RxLLC)
The FDA approved NorthStar RxLLC's generic nitrofurantoin monohydrate/macrocrystals (ANDA) for treating urinary tract infections.
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FDA approval · 2023-05-11FDA Approved: NITROFURANTOIN — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the original application for nitrofurantoin, granting a generic version from Rising Pharma Holdings, Inc.
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FDA approval · 2023-04-28FDA Approved: NITROFURANTOIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA granted supplemental approval for nitrofurantoin filed by Amneal Pharmaceuticals NY LLC (ANDA201679), authorizing its marketing as a gen…
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FDA approval · 2023-04-14FDA Approved: NITROFURANTOIN — Original Application (NorthStar Rx LLC)
The FDA approved NorthStar Rx LLC's original application for nitrofurantoin, a generic antibiotic used to treat urinary tract infections.
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FDA approval · 2023-03-30FDA Approved: NITROFURANTOIN — Original Application (Aurobindo Pharma Limited)
FDA approved a generic nitrofurantoin product (nitrofurantoin monohydrate/macrocrystals) under an Original Application (ANDA209225) from Aur…
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FDA approval · 2023-03-21FDA Approved: NITROFURANTOIN MACROCRYSTALS — Original Application (Lifestar Pharma LLC)
FDA approved the generic nitrofurantoin macrocrystals from Lifestar Pharma LLC through an ANDA, enabling a generic version for treating urin…
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FDA approval · 2023-03-02FDA Approved: NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE — Supplemental Application (Alvogen Inc.)
FDA approved a supplemental application for nitrofurantoin monohydrate/macrocrystalline from Alvogen Inc., granting approval for the request…
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FDA approval · 2022-11-02FDA Approved: AMOXICILLIN — Supplemental Application (USAntibiotics, LLC)
FDA approved a supplemental application for Amoxicillin submitted by USAntibiotics, LLC.
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FDA approval · 2022-03-18FDA Approved: CEFEPIME HYDROCHLORIDE AND DEXTROSE — Supplemental Application (B. Braun Medical Inc.)
FDA approved a supplemental application for Cefepime hydrochloride and dextrose from B. Braun Medical Inc.
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FDA approval · 2022-02-18FDA Approved: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) — Original Application (Jubilant Cadista Pharmaceuticals Inc.)
FDA approved Jubilant Cadista Pharmaceuticals' generic nitrofurantoin monohydrate/macrocrystals (ANDA) as a bioequivalent generic product.
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FDA approval · 2022-02-08FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)
The FDA approved a supplemental application for Nitrofurantoin Macrocrystals from Zydus Pharmaceuticals (USA) Inc., updating an aspect of th…
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FDA approval · 2022-01-26FDA Approved: FOSFOMYCIN TROMETHAMINE — Original Application (Cipla USA Inc.)
FDA approved the original application for fosfomycin tromethamine, a generic antibiotic, manufactured by Cipla USA Inc.
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FDA approval · 2021-12-28FDA Approved: METHENAMINE HIPPURATE — Supplemental Application (Esjay Pharma LLC)
The FDA approved a supplemental application for Methenamine Hippurate submitted by Esjay Pharma LLC. The snippet confirms an approved supple…
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FDA approval · 2021-10-21FDA Approved: FOSFOMYCIN TROMETHAMINE — Original Application (Kesin Pharma Corporation)
The FDA approved Kesin Pharma Corporation's original ANDA for fosfomycin tromethamine, authorizing the marketing of a generic antibiotic.
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FDA approval · 2021-06-25FDA Approved: NITROFURANTOIN — Original Application (Alembic Pharmaceuticals Limited)
FDA approves Alembic Pharmaceuticals Limited's original application for nitrofurantoin, a generic antibiotic for urinary tract infections.
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FDA approval · 2021-01-21FDA Approved: NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE — Supplemental Application (Alvogen Inc.)
The FDA approved a supplemental application for nitrofurantoin monohydrate/macrocrystalline (Alvogen). This action confirms regulatory autho…
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FDA approval · 2021-01-21FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Alvogen Inc.)
The FDA approved a supplemental application for Nitrofurantoin Macrocrystals from Alvogen, approving the new formulation and related labelin…
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FDA approval · 2020-12-23FDA Approved: NITROFURANTOIN — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for nitrofurantoin filed by Rising Pharma Holdings, Inc., reflecting a change to the drug's labe…
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FDA approval · 2020-11-27FDA Approved: METHENAMINE HIPPURATE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved the original application for methenamine hippurate, a generic product from Ingenus Pharmaceuticals, LLC. It is indicated for th…
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FDA approval · 2020-07-28FDA Approved: BACTRIM — Supplemental Application (Sun Pharmaceutical Industries, Inc)
FDA approved a supplemental application for BACTRIM (sulfamethoxazole and trimethoprim) filed by Sun Pharmaceutical Industries, Inc. to upda…
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FDA approval · 2020-04-22FDA Approved: LEVOFLOXACIN — Original Application (Gland Pharma Limited)
FDA approved an original application for levofloxacin from Gland Pharma Limited, authorizing a generic version of the antibiotic.
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FDA approval · 2020-01-27FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for Amoxicillin and clavulanate potassium by Sandoz Inc.