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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202207
Company: CARDINAL HEALTH 414

Summary Review

Products on NDA 202207

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202207

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.html 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
05/19/2021	SUPPL-12	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202207s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202207Orig1s012ltr.pdf
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

Labels for NDA 202207

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/19/2021	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202207s012lbl.pdf
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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