Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103964
Company: zr pharma&
Company: zr pharma&
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEGASYS | PEGINTERFERON ALFA-2A | 180UG/VIAL | VIAL; SUBCUTANEOUS | Prescription | None | No | No |
| PEGASYS | PEGINTERFERON ALFA-2A | 180U/5ML | 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 |
|---|---|---|---|---|---|---|---|
| 10/16/2002 | ORIG-1 | Approval | N/A |
Label
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegihof101602LB.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/pegihof101602L.htm https://web.archive.org/web/20170113111452/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080721.htm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/11/2023 | SUPPL-5276 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103964s5276lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103964Orig1s5276ltr.pdf | |
| 03/24/2021 | SUPPL-5275 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103964s5275lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103964Orig1s5275ltr.pdf | |
| 10/15/2020 | SUPPL-5273 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103964s5273lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103964Orig1s5273ltr.pdf | |
| 10/13/2017 | SUPPL-5270 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103964Orig1s5270ltr.pdf | |
| 03/18/2015 | SUPPL-5264 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103964s5264lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103964Orig1s5264ltr.pdf | |
| 09/05/2014 | SUPPL-5261 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103964s5261lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103964Orig1s5261ltr.pdf | |
| 07/02/2013 | SUPPL-5245 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103964s5245lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103964Orig1s5245ltr.pdf | |
| 05/16/2013 | SUPPL-5241 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103964s5241lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103964Orig1s5241ltr.pdf | |
| 05/09/2011 | SUPPL-5216 | Supplement |
Label is not available on this site. |
||
| 08/22/2011 | SUPPL-5213 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5213lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s023,103964s5213ltr.pdf | |
| 09/29/2011 | SUPPL-5204 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5204lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103964s5204ltr.pdf | |
| 08/09/2011 | SUPPL-5186 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5186lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s022,103964s5186ltr.pdf | |
| 05/27/2011 | SUPPL-5184 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5184lbl.pdf | |
| 02/23/2011 | SUPPL-5183 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5183lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103964s5183ltr.pdf | |
| 03/03/2010 | SUPPL-5177 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103964s5177ltr.pdf |
| 05/24/2010 | SUPPL-5176 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103964s5176ltr.pdf |
| 08/07/2009 | SUPPL-5171 | Supplement |
Label is not available on this site. |
||
| 04/20/2009 | SUPPL-5163 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103964s5147, 103964s5163lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103964s5147,103964s5163ltr.pdf | |
| 09/18/2008 | SUPPL-5154 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103964s5154lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103964s5154ltr.pdf | |
| 04/20/2009 | SUPPL-5147 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103964s5147, 103964s5163lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103964s5147,103964s5163ltr.pdf | |
| 06/13/2008 | SUPPL-5144 | Supplement |
Label is not available on this site. |
||
| 06/13/2008 | SUPPL-5139 | Supplement |
Label is not available on this site. |
||
| 10/31/2008 | SUPPL-5133 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103964s5133lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103964s5133ltr.pdf | |
| 06/19/2007 | SUPPL-5120 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103964s5120lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103964s5120ltr.pdf | |
| 11/18/2005 | SUPPL-5076 | Supplement |
Label is not available on this site. |
||
| 05/13/2005 | SUPPL-5065 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964s5065ltr.pdf |
| 05/13/2005 | SUPPL-5057 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964s5057ltr.pdf |
| 02/25/2005 | SUPPL-5039 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103964_5039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964_5039ltr.pdf | |
| 05/13/2005 | SUPPL-5037 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103964s5037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964s5037ltr.pdf | |
| 12/21/2004 | SUPPL-5036 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103964_5036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103964_5036ltr.pdf | |
| 10/31/2003 | SUPPL-5016 | Supplement |
Label is not available on this site. |
||
| 12/03/2002 | SUPPL-5000 | Supplement |
Label
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegihof120302LB.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/pegihof120302L.htm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/11/2023 | SUPPL-5276 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103964s5276lbl.pdf | |
| 03/24/2021 | SUPPL-5275 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103964s5275lbl.pdf | |
| 10/15/2020 | SUPPL-5273 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103964s5273lbl.pdf | |
| 10/15/2020 | SUPPL-5273 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103964s5273lbl.pdf | |
| 10/13/2017 | SUPPL-5270 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf | |
| 03/18/2015 | SUPPL-5264 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103964s5264lbl.pdf | |
| 09/05/2014 | SUPPL-5261 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103964s5261lbl.pdf | |
| 07/02/2013 | SUPPL-5245 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103964s5245lbl.pdf | |
| 05/16/2013 | SUPPL-5241 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103964s5241lbl.pdf | |
| 09/29/2011 | SUPPL-5204 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5204lbl.pdf | |
| 08/22/2011 | SUPPL-5213 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5213lbl.pdf | |
| 08/09/2011 | SUPPL-5186 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5186lbl.pdf | |
| 05/27/2011 | SUPPL-5184 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5184lbl.pdf | |
| 02/23/2011 | SUPPL-5183 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5183lbl.pdf | |
| 04/20/2009 | SUPPL-5163 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103964s5147, 103964s5163lbl.pdf | |
| 04/20/2009 | SUPPL-5147 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103964s5147, 103964s5163lbl.pdf | |
| 10/31/2008 | SUPPL-5133 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103964s5133lbl.pdf | |
| 09/18/2008 | SUPPL-5154 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103964s5154lbl.pdf | |
| 06/19/2007 | SUPPL-5120 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103964s5120lbl.pdf | |
| 05/13/2005 | SUPPL-5037 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103964s5037lbl.pdf | |
| 02/25/2005 | SUPPL-5039 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103964_5039lbl.pdf | |
| 12/21/2004 | SUPPL-5036 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103964_5036lbl.pdf | |
| 12/03/2002 | SUPPL-5000 | Efficacy | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegihof120302LB.htm | ||
| 10/16/2002 | ORIG-1 | Approval | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegihof101602LB.htm |