Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202207
Company: CARDINAL HEALTH 414
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 |
---|---|---|---|---|---|
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 |
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 |