Intra-abdominal Infections
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-02-13FDA Approved: METRONIDAZOLE — Original Application (Viona Pharmaceuticals Inc)
FDA approved the original ANDA for metronidazole from Viona Pharmaceuticals Inc, enabling a generic version of the antibiotic to be marketed…
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FDA approval · 2025-08-21FDA Approved: MEROPENEM — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for Meropenem submitted by BluePoint Laboratories (ANDA205883), confirming approval of a supplementa…
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FDA approval · 2025-02-14FDA Approved: METRONIDAZOLE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved a supplemental application for metronidazole from Alembic Pharmaceuticals Limited.
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FDA approval · 2024-12-17FDA Approved: METRONIDAZOLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Metronidazole from Sun Pharmaceutical Industries, Inc., resulting in continued approval of this …
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FDA approval · 2024-11-19FDA Approved: ZOSYN IN GALAXY CONTAINERS — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application to allow Zosyn in Galaxy containers (piperacillin/tazobactam), a packaging/formulation change from W…
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FDA approval · 2024-10-25FDA Approved: METRONIDAZOLE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Metronidazole filed by Aurobindo Pharma Limited, authorizing the generic product under the suppl…
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FDA approval · 2024-10-25FDA Approved: METRONIDAZOLE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approves a supplemental application for Metronidazole from Alembic Pharmaceuticals Limited, confirming continued approval of the generic…
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CLINICAL_TRIALS trial_result · 2024-10-09Clinical Trial Update: Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI [Phase 3]
A Phase 3 clinical trial update indicates a study evaluating the efficacy and safety of Meropenem combined with Pralurbactam for intra-abdom…
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FDA approval · 2024-07-11FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Micro Labs Limited)
FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium from Micro Labs Limited under ANDA217805.
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FDA approval · 2024-06-18FDA Approved: METRONIDAZOLE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved a supplemental application for Metronidazole from Alembic Pharmaceuticals Limited, granting approval for a generic version of t…
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FDA approval · 2024-06-13FDA Approved: ERTAPENEM — Supplemental Application (Eugia US LLC)
FDA approved a supplemental application for Ertapenem (ERTAPENEM) by Eugia US LLC. The action relates to a modification/expansion of the dru…
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FDA approval · 2024-05-01FDA Approved: PIPERACILLIN AND TAZOBACTAM — Supplemental Application (Eugia US LLC)
FDA approved a supplemental ANDA for Piperacillin and Tazobactam (piperacillin sodium and tazobactam sodium) manufactured by Eugia US LLC.
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FDA approval · 2024-05-01FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Northstar RxLLC)
FDA approved a supplemental application for Amoxicillin and clavulanate potassium (amoxicillin-clavulanate) from Northstar RxLLC, authorizin…
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FDA approval · 2023-12-11FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis, Inc.)
FDA approved an Original Application for amoxicillin and clavulanate potassium (amoxicillin/clavulanate) as a generic antibiotic formulation…
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FDA label_change · 2023-11-22FDA Approved: METRONIDAZOLE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for metronidazole from Prasco Laboratories, indicating an updated labeling/approval for an additiona…
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FDA approval · 2023-10-17FDA Approved: METRONIDAZOLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for Metronidazole filed by Sun Pharmaceutical Industries, Inc., updating the drug’s labeling as …
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FDA approval · 2023-10-12FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Eugia US LLC)
FDA approved the original abbreviated new drug application for piperacillin and tazobactam, a combination antibiotic manufactured by Eugia U…
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FDA approval · 2023-09-15FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis, Inc.)
FDA approves a generic amoxicillin/clavulanate potassium product under an Original Application by Devatis, Inc.
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FDA approval · 2023-09-13FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis Inc.)
FDA approved a generic Amoxicillin and clavulanate potassium product under Original Application by Devatis Inc.
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FDA approval · 2023-04-21FDA Approved: METRONIDAZOLE — Original Application (Viona Pharmaceuticals Inc)
The FDA approved Viona Pharmaceuticals' original application for metronidazole, granting a generic version of the antibiotic/antiprotozoal.
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FDA approval · 2022-03-31FDA Approved: METRONIDAZOLE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for metronidazole from Aurobindo Pharma Limited, indicating a supplemental approval for this generic…
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FDA approval · 2022-02-08FDA Approved: ERTAPENEM — Supplemental Application (Apotex Corp)
FDA approved a supplemental application for Apotex Corp to market ertapenem sodium (ERTAPENEM) as a generic antibiotic.
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FDA approval · 2021-12-15FDA Approved: METRONIDAZOLE — Supplemental Application (Baxter Healthcare Corporation)
The FDA approved a supplemental application for metronidazole from Baxter Healthcare Corporation.
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FDA approval · 2021-11-12FDA Approved: VANCOMYCIN HYDROCHLORIDE — Supplemental Application (Plano Pharmaceuticals Inc.)
The FDA approved a supplemental application for Vancomycin hydrochloride by Plano Pharmaceuticals Inc., approving changes to the approved dr…
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FDA approval · 2021-10-14FDA Approved: METRONIDAZOLE — Original Application (Solaris Pharma Corporation)
FDA approved Solaris Pharma Corporation's generic metronidazole (METRONIDAZOLE) under an original ANDA.