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Biologic License Application (BLA): 103964
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
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
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
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