Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 065430
Company: B BRAUN
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 Prescription None Yes Yes
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER CEFOTETAN DISODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION 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
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
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.

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