Intra-abdominal Infection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-04-25FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (NorthStar Rx LLC)
FDA approved a Supplemental Application for Amoxicillin and clavulanate potassium by NorthStar Rx LLC, indicating a modification to an exist…
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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 · 2022-03-16FDA Approved: METRONIDAZOLE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for METRONIDAZOLE submitted by Prasco Laboratories.
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FDA approval · 2021-08-19FDA Approved: METRONIDAZOLE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
The FDA approved a supplemental application for METRONIDAZOLE submitted by Unichem Pharmaceuticals (USA), Inc., signaling an approved change…
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FDA approval · 2021-04-16FDA Approved: AZACTAM — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
FDA approved a supplemental application for AZACTAM (aztreonam) from E.R. Squibb & Sons, L.L.C. The approval updates the product labeling fo…
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FDA approval · 2021-03-05FDA Approved: METRONIDAZOLE — Supplemental Application (Baxter Healthcare Corporation)
The FDA approved a supplemental application for Metronidazole submitted by Baxter Healthcare Corporation.
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FDA approval · 2021-02-16FDA Approved: PIPERACILLIN, TAZOBACTAM — Original Application (Sagent Pharmaceuticals)
FDA approves Sagent Pharmaceuticals' generic Piperacillin-tazobactam for intravenous use under Original Application, enabling a generic vers…
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FDA approval · 2020-09-09FDA Approved: CEFTRIAXONE AND DEXTROSE — Supplemental Application (B. Braun Medical Inc.)
FDA approved a supplemental application for Ceftriaxone and Dextrose from B. Braun Medical, resulting in an updated/expanded approval for th…
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FDA approval · 2020-08-03FDA Approved: METRONIDAZOLE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' generic metronidazole (ANDA 212435), enabling a generic version of metronidazole for its establi…
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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.
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FDA approval · 2019-08-16FDA Approved: MEROPENEM — Original Application (WG Critical Care, LLC)
FDA approved WG Critical Care, LLC's original ANDA for Meropenem, providing a generic version of the carbapenem antibiotic.
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FDA approval · 2019-07-29FDA Approved: METRONIDAZOLE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Metronidazole from Aurobindo Pharma Limited, updating an existing generic product approval.
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FDA approval · 2019-02-25FDA Approved: METRONIDAZOLE — Original Application (Hospira, Inc.)
FDA approves Hospira's original application for metronidazole (generic) for use in several anaerobic bacterial infections and protozoal infe…
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CLINICAL_TRIALS trial_result · 2018-12-24Clinical Trial Update: Tygacil Drug Use Investigation
Pfizer reports a completed trial investigating tigecycline (Tygacil) for intra-abdominal infections and skin infections, with results posted…
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CLINICAL_TRIALS trial_result · 2018-07-12Clinical Trial Update: Study of Ceftolozane/Tazobactam (MK-7625A) in Combination With Metronidazole in Japanese Participants With Complicated Intra-abdominal Infection (MK-7625A-013) [Phase 3]
Phase 3 trial of ceftolozane/tazobactam plus metronidazole in Japanese adults with complicated intra-abdominal infection has completed with …
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FDA approval · 2018-06-25FDA Approved: ERTAPENEM — Original Application (Eugia US LLC)
The FDA approved an original application for ertapenem from Eugia US LLC, authorizing a generic version of the carbapenem antibiotic ertapen…
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CLINICAL_TRIALS trial_result · 2018-04-09Clinical Trial Update: A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection [Phase 4]
Phase 4 trial comparing tigecycline to imipenem/cilastatin for complicated intra-abdominal infection; results were posted in 2018.
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FDA approval · 2018-04-03FDA Approved: FLAGYL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for Flagyl (metronidazole) from Pfizer Laboratories Div Pfizer Inc, resulting in changes to the …
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FDA approval · 2017-12-12FDA Approved: METRONIDAZOLE — Original Application (Cadila Pharmaceuticals Limited)
FDA approved Cadila Pharmaceuticals' generic metronidazole under an Original Application (ANDA209794).
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FDA approval · 2017-12-04FDA Approved: METRONIDAZOLE — Supplemental Application (Baxter Healthcare Corporation)
The FDA approved a supplemental application for Metronidazole from Baxter Healthcare Corporation, typically reflecting labeling updates or o…
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CLINICAL_TRIALS trial_result · 2017-08-29Clinical Trial Update: Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients
Clinical trial update on target-site pharmacokinetics of doripenem at steady state in intubated ICU patients (completed).
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CLINICAL_TRIALS trial_result · 2017-02-23Clinical Trial Update: Deescalating Carbapenems in Hospital Setting [Phase 4]
A Phase 4 trial evaluating de-escalation of carbapenems in hospitalized patients with urinary tract, intra-abdominal, and biliary tract infe…
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CLINICAL_TRIALS trial_result · 2017-02-20Clinical Trial Update: A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802) [Phase 3]
A Phase 3 study comparing ertapenem to ceftriaxone plus metronidazole for intra-abdominal infections in adults has completed.
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FDA approval · 2017-01-13FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Provepharm Inc.)
FDA approved a generic combination product of piperacillin and tazobactam (piperacillin sodium and tazobactam sodium) from Provepharm Inc. u…
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FDA approval · 2016-11-16FDA Approved: METRONIDAZOLE — Original Application (Viona Pharmaceuticals Inc)
FDA approved Metronidazole via an original application from Viona Pharmaceuticals Inc (ANDA206560). The approval confirms its use for anaero…