Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125031
Company: AMGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEULASTA PEGFILGRASTIM 6MG/0.6ML 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
01/31/2002 ORIG-1 Approval N/A Label (PDF)
Letter
Patient Package Insert (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegfamg013102LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/pegfamg013102L.htm https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegfamg013102ptLB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125031_0000_NeulastaTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/16/2019 SUPPL-198 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125031s198lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125031Orig1s198ltr.pdf
06/18/2018 SUPPL-193 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125031s193lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125031Orig1s193ltr.pdf
12/09/2017 SUPPL-191 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125031s189s191lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125031Orig1s189,s191ltr.pdf
12/09/2017 SUPPL-189 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125031s189s191lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125031Orig1s189,s191ltr.pdf
04/28/2016 SUPPL-184 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125031s184lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125031Orig1s184ltr.pdf
09/23/2015 SUPPL-181 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s170s179s181lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s170,s179,s181ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125031Orig1s181.pdf
11/13/2015 SUPPL-180 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s180lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s180ltr.pdf
09/23/2015 SUPPL-179 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s170s179s181lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s170,s179,s181ltr.pdf
12/23/2014 SUPPL-175 Supplement Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125031Orig1s175ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125031Orig1s175.pdf
09/23/2015 SUPPL-170 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s170s179s181lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s170,s179,s181ltr.pdf
05/25/2012 SUPPL-142 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125031s0142lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125031s0142ltr.pdf
06/03/2011 SUPPL-130 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125031s130ltr.pdf
02/17/2010 SUPPL-120 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125031s120ltr.pdf
11/14/2008 SUPPL-105 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125031s091s105ltr.pdf
04/16/2008 SUPPL-95 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125031s0095ltr.pdf
11/14/2008 SUPPL-91 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125031s091s105ltr.pdf
07/23/2007 SUPPL-82 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125031s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125031s082ltr.pdf
10/25/2006 SUPPL-72 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125031s072LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125031s072LTR.pdf
09/15/2005 SUPPL-52 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125031s0052lbl.pdf
01/24/2005 SUPPL-51 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125031_0051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125031_0051ltr.pdf
12/17/2004 SUPPL-48 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125031_0048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125031_0048ltr.pdf
11/24/2004 SUPPL-43 Supplement

Label is not available on this site.

11/03/2004 SUPPL-39 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/16/2019 SUPPL-198 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125031s198lbl.pdf
06/18/2018 SUPPL-193 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125031s193lbl.pdf
06/18/2018 SUPPL-193 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125031s193lbl.pdf
12/09/2017 SUPPL-191 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125031s189s191lbl.pdf
12/09/2017 SUPPL-189 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125031s189s191lbl.pdf
04/28/2016 SUPPL-184 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125031s184lbl.pdf
11/13/2015 SUPPL-180 Efficacy-Animal Rule Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s180lbl.pdf
09/23/2015 SUPPL-181 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s170s179s181lbl.pdf
09/23/2015 SUPPL-179 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s170s179s181lbl.pdf
09/23/2015 SUPPL-170 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s170s179s181lbl.pdf
05/25/2012 SUPPL-142 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125031s0142lbl.pdf
07/23/2007 SUPPL-82 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125031s082lbl.pdf
10/25/2006 SUPPL-72 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125031s072LBL.pdf
09/15/2005 SUPPL-52 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125031s0052lbl.pdf
01/24/2005 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125031_0051lbl.pdf
12/17/2004 SUPPL-48 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125031_0048lbl.pdf
01/31/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegfamg013102LB.pdf

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