Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761137
Company: ASTELLAS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PADCEV ENFORTUMAB VEDOTIN-EJFV 20MG/VIAL INJECTABLE;INJECTION Prescription None No No
PADCEV ENFORTUMAB VEDOTIN-EJFV 30MG/VIAL INJECTABLE;INJECTION Prescription None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/18/2019 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761137s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761137Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761137Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/22/2021 SUPPL-7 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761137s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761137Orig1s007ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/22/2021 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761137s007lbl.pdf
12/18/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761137s000lbl.pdf

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