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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761196
Company: ADC Therapeutics SA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYNLONTA LONCASTUXIMAB TESIRINE-LPYL 10MG 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
04/23/2021 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761196s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761196Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761196Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/12/2022 SUPPL-5 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761196s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761196Orig1s004,s005ltr.pdf
10/12/2022 SUPPL-4 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761196s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761196Orig1s004,s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/12/2022 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761196s004s005lbl.pdf
10/12/2022 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761196s004s005lbl.pdf
04/23/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761196s000lbl.pdf
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