Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202106
Company: B BRAUN MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER MEROPENEM 500MG/VIAL POWDER;INTRAVENOUS Prescription None No No
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER MEROPENEM 1GM/VIAL POWDER;INTRAVENOUS Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/30/2015 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202106Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/202106Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/202106Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/12/2020 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202106s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202106Orig1s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202106Orig1s007ltr.pdf
01/19/2018 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202106s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202106Orig1s003ltr.pdf
12/15/2015 SUPPL-1 Manufacturing (CMC) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/12/2020 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202106s007lbl.pdf
01/19/2018 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202106s003lbl.pdf
04/30/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202106lbl.pdf

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