Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125031
Company: AMGEN
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 |
|---|---|---|---|---|---|
| 02/02/2021 | SUPPL-203 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125031s203lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125031Orig1s203ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/125031Orig1s203_LabelingR.pdf | |
| 01/05/2021 | SUPPL-202 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125031s202lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125031Orig1s202ltr.pdf | |
| 11/18/2020 | SUPPL-201 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125031s201lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125031Orig1s201ltr.pdf | |
| 01/06/2020 | SUPPL-199 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125031s199lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125031Orig1s199ltr.pdf | |
| 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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s180lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s180ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125031Orig1s180.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 |
|---|---|---|---|---|---|
| 02/02/2021 | SUPPL-203 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125031s203lbl.pdf | |
| 01/05/2021 | SUPPL-202 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125031s202lbl.pdf | |
| 01/05/2021 | SUPPL-202 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125031s202lbl.pdf | |
| 11/18/2020 | SUPPL-201 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125031s201lbl.pdf | |
| 11/18/2020 | SUPPL-201 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125031s201lbl.pdf | |
| 01/06/2020 | SUPPL-199 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125031s199lbl.pdf | |
| 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 |