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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018900
Company: B BRAUN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METRO I.V. IN PLASTIC CONTAINER METRONIDAZOLE 500MG/100ML INJECTABLE;INJECTION Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/23/2026 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/018900s046lbl.pdf
03/14/2025 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018900s045lbl.pdf
07/08/2024 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018900s043lbl.pdf
12/15/2021 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018900s041lbl.pdf
04/29/2021 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018900s038lbl.pdf
03/05/2021 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018900s039lbl.pdf
04/11/2018 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018900s035lbl.pdf
12/08/2015 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018900s031lbl.pdf
07/13/2015 SUPPL-32 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018900s032lbl.pdf
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