Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050823
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFTAZIDIME IN DEXTROSE CONTAINER CEFTAZIDIME EQ 1GM BASE INJECTABLE;INJECTION Prescription None Yes No
CEFTAZIDIME IN DEXTROSE CONTAINER CEFTAZIDIME EQ 2GM BASE 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
06/13/2011 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)
Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050823s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050823_ceftazidime_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050823Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2019 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050823s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050823Orig1s007ltr.pdf
05/15/2015 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050823s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050823Orig1s004ltr.pdf
04/01/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/29/2019 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050823s007lbl.pdf
05/15/2015 SUPPL-4 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050823s004lbl.pdf

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