Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202207
Company: CARDINAL HEALTH 414
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LYMPHOSEEK KIT TECHNETIUM TC-99M TILMANOCEPT N/A 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
03/13/2013 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202207s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202207Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202207Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202207Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/08/2019 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202207s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202207Orig1s009ltr.pdf
11/30/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/20/2016 SUPPL-5 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202207s005lbl.pdf
08/03/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/14/2014 SUPPL-2 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202207s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202207Orig1s002ltr.pdf
06/13/2014 SUPPL-1 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202207s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202207Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/08/2019 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202207s009lbl.pdf
10/20/2016 SUPPL-5 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202207s005lbl.pdf
10/14/2014 SUPPL-2 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202207s002lbl.pdf
06/13/2014 SUPPL-1 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202207s001lbl.pdf
03/13/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202207s000lbl.pdf

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