Drugs@FDA: FDA-Approved Drugs

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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
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.

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

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