Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103353
Company: AMGEN
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 |
|---|---|---|---|---|---|
| 04/18/2023 | SUPPL-5198 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103353s5198lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103353Orig1s5198ltr.pdf | |
| 02/04/2021 | SUPPL-5197 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103353s5197lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103353Orig1s5197ltr.pdf | |
| 01/05/2021 | SUPPL-5196 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103353s5196lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103353orig1s5196ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 04/18/2023 | SUPPL-5198 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103353s5198lbl.pdf | |
| 02/04/2021 | SUPPL-5197 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103353s5197lbl.pdf | |
| 01/05/2021 | SUPPL-5196 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103353s5196lbl.pdf | |
| 01/05/2021 | SUPPL-5196 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103353s5196lbl.pdf | |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103353s5188.pdf | |
| 06/29/2016 | SUPPL-5188 | Labeling-Patient 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 |