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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202106
Company: B BRAUN MEDICAL INC

Summary Review

Products on NDA 202106

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202106

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.

Labels for NDA 202106

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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