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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761073
Company: AMGEN INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KANJINTI TRASTUZUMAB-ANNS 420MG VIAL; MULTIDOSE Prescription None No No
KANJINTI TRASTUZUMAB-ANNS 150MG VIAL;SINGLE-DOSE 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
06/13/2019 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761073Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761073Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761073Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2019 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761073Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761073Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/25/2019 SUPPL-1 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761073Orig1s001lbl.pdf
06/13/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761073Orig1s000lbl.pdf
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