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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206056
Company: B BRAUN MEDICAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL POWDER;INTRAVENOUS Prescription None Yes Yes
PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL POWDER;INTRAVENOUS Prescription None Yes Yes
PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/03/2025 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206056s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/206056Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/206056Orig1s000TOC.html

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/03/2025 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206056s000lbl.pdf
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