Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125553
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZARXIO FILGRASTIM-SNDZ 300 mcg/0.5 mL INJECTABLE;INJECTION Prescription None No No
ZARXIO FILGRASTIM-SNDZ 480 mcg/0.8 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
03/06/2015 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125553lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125553Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/01/2019 SUPPL-17 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125553s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125553Orig1s017ltr.pdf
02/17/2017 SUPPL-7 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125553s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125553Orig1s007ltr.pdf
03/03/2016 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125553s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125553Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/01/2019 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125553s017lbl.pdf
02/17/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125553s007lbl.pdf
02/17/2017 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125553s007lbl.pdf
02/17/2017 SUPPL-7 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125553s007lbl.pdf
03/03/2016 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125553s001lbl.pdf
03/06/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125553lbl.pdf

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