Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 761088
Company: CELLTRION INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRUXIMA RITUXIMAB-ABBS 100MG/10ML(10MG/ML) INJECTABLE;INJECTION Prescription None No No
TRUXIMA RITUXIMAB-ABBS 500MG/50ML(10MG/ML) 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
11/28/2018 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761088s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761088Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761088Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/23/2019 SUPPL-2 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761088Orig1s001s002_Replacementlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761088Orig1s001s002Replacementltr.pdf
05/23/2019 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761088Orig1s001s002_Replacementlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761088Orig1s001s002Replacementltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/23/2019 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761088Orig1s001s002_Replacementlbl.pdf
05/23/2019 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761088Orig1s001s002_Replacementlbl.pdf
11/28/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761088s000lbl.pdf

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