Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125294
Company: SICOR BIOTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRANIX TBO-FILGRASTIM 300MCG/0.5ML INJECTABLE; INJECTION Prescription None No No
GRANIX TBO-FILGRASTIM 480MCG/0.8ML 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
08/29/2012 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125294s0000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125294Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125294Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125294Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/09/2019 SUPPL-48 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125294Orig1s048ltr.pdf
03/28/2019 SUPPL-46 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125294s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125294Orig1s046ltr.pdf
07/31/2018 SUPPL-45 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125294s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125294Orig1s045ltr.pdf
06/21/2017 SUPPL-42 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125294Orig1s042ltr.pdf
02/02/2017 SUPPL-40 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125294Orig1s040ltr.pdf
12/19/2014 SUPPL-35 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125294s035lbl.pdf
07/19/2013 SUPPL-7 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125294s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125294Orig1s007ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/28/2019 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125294s046lbl.pdf
07/31/2018 SUPPL-45 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125294s045lbl.pdf
06/21/2017 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s042lbl.pdf
02/02/2017 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s040lbl.pdf
02/02/2017 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s040lbl.pdf
12/19/2014 SUPPL-35 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125294s035lbl.pdf
12/19/2014 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125294s035lbl.pdf
12/19/2014 SUPPL-35 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125294s035lbl.pdf
07/19/2013 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125294s007lbl.pdf
08/29/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125294s0000lbl.pdf

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