Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 761091
Company: CELLTRION INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HERZUMA TRASTUZUMAB-PKRB 420MG 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
12/14/2018 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761091s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761091Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761091Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/16/2019 SUPPL-2 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761091s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761091Orig1s001, s002ltr.pdf
05/16/2019 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761091s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761091Orig1s001, s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/16/2019 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761091s001s002lbl.pdf
05/16/2019 SUPPL-1 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761091s001s002lbl.pdf
12/14/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761091s000lbl.pdf

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