Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 065430
Company: B BRAUN

Products on NDA 065430

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	CEFOTETAN DISODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	Yes	No
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	CEFOTETAN DISODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 065430

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/09/2007	ORIG-1	Approval		UNKNOWN	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/065430ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2020	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/065430s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/065430Orig1s009ltr.pdf
12/18/2013	SUPPL-6	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 065430

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2020	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/065430s009lbl.pdf