Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103353
Company: AMGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEUPOGEN FILGRASTIM 300MCG/1ML VIAL Prescription None No No
NEUPOGEN FILGRASTIM 480MCG/1.6ML VIAL Prescription None No No
NEUPOGEN FILGRASTIM 300MGC/0.5ML SYRINGE Prescription None No No
NEUPOGEN FILGRASTIM 480MCG/0.8ML SYRINGE 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
02/20/1991 ORIG-1 Approval N/A Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/bla/pre96/103353Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/18/2018 SUPPL-5194 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103353s5194lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103353Orig1s5194ltr.pdf
06/29/2016 SUPPL-5188 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103353s5188.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103353Orig1s5188ltr.pdf
07/30/2015 SUPPL-5186 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5186lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103353Orig1s5186ltr.pdf
02/06/2015 SUPPL-5184 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5184lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103353Orig1s5184ltr.pdf
03/30/2015 SUPPL-5183 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5183lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103353Orig1s5183ltr.pdf
09/13/2013 SUPPL-5157 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103353s5157lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103353Orig1s5157ltr.pdf
05/25/2012 SUPPL-5147 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103353s5147lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103353s5147ltr.pdf
03/02/2010 SUPPL-5127 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103353_5127lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103353s5127ltr.pdf
09/27/2007 SUPPL-5099 Supplement

Label is not available on this site.

10/25/2006 SUPPL-5086 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103353s5086LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103353s5086LTR.pdf
12/17/2004 SUPPL-5059 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103353_5059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103353_5059ltr.pdf
11/24/2004 SUPPL-5058 Supplement

Label is not available on this site.

05/29/2002 SUPPL-5001 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/filgamg052902LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/filgamg052902L.pdf
06/21/2001 SUPPL-1051 Supplement

Label is not available on this site.

04/02/1998 SUPPL-1036 Supplement Label (PDF)
Letter
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/filgamg040298lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/filgamg040298L.htm
12/28/1995 SUPPL-1027 Supplement

Label is not available on this site.

06/15/1994 SUPPL-1009 Supplement

Label is not available on this site.

12/19/1994 SUPPL-1007 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/18/2018 SUPPL-5194 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103353s5194lbl.pdf
06/29/2016 SUPPL-5188 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103353s5188.pdf
06/29/2016 SUPPL-5188 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103353s5188.pdf
07/30/2015 SUPPL-5186 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5186lbl.pdf
03/30/2015 SUPPL-5183 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5183lbl.pdf
02/06/2015 SUPPL-5184 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5184lbl.pdf
09/13/2013 SUPPL-5157 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103353s5157lbl.pdf
05/25/2012 SUPPL-5147 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103353s5147lbl.pdf
03/02/2010 SUPPL-5127 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103353_5127lbl.pdf
10/25/2006 SUPPL-5086 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103353s5086LBL.pdf
12/17/2004 SUPPL-5059 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103353_5059lbl.pdf
05/29/2002 SUPPL-5001 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/filgamg052902LB.pdf
04/02/1998 SUPPL-1036 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/filgamg040298lb.pdf

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