Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 761042
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERELZI ETANERCEPT-SZZS 25MG/0.5ML INJECTABLE; INJECTION Prescription None No No
ERELZI ETANERCEPT-SZZS 50MG/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
08/30/2016 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761042Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761042Orig1_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761042Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/26/2018 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761042s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761042Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761042Orig1s01.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/26/2018 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761042s001lbl.pdf
01/26/2018 SUPPL-1 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761042s001lbl.pdf
08/30/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761042lbl.pdf

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