Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103949
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEGINTRON PEGINTERFERON ALFA-2B 50UG/0.5ML VIAL Prescription None No No
PEGINTRON PEGINTERFERON ALFA-2B 80UG/0.5ML VIAL Prescription None No No
PEGINTRON PEGINTERFERON ALFA-2B 120UG/0.5ML VIAL Prescription None No No
PEGINTRON PEGINTERFERON ALFA-2B 150UG/0.5ML VIAL Prescription None No No
PEGINTRON PEGINTERFERON ALFA-2B 50UG/0.5ML SYRINGE Prescription None No No
PEGINTRON PEGINTERFERON ALFA-2B 80UG/0.5ML SYRINGE Prescription None No No
PEGINTRON PEGINTERFERON ALFA-2B 150UG/0.5ML SYRINGE Prescription None No No
PEGINTRON PEGINTERFERON ALFA-2B 120UG/0.5ML SYRINGE Prescription None No No
SYLATRON PEGINTERFERON ALFA-2B 296 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL VIAL Prescription None No No
SYLATRON PEGINTERFERON ALFA-2B 444 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL VIAL Prescription None No No
SYLATRON PEGINTERFERON ALFA-2B 888 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL VIAL 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
01/19/2001 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/pegsche011901LB.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/pegsche011901L.htm https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080727.htm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/25/2017 SUPPL-5304 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103949s5304lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103949Orig1s5304ltr.pdf
09/16/2015 SUPPL-5299 Supplement Label (PDF)
Letter (PDF)
Label for PEGINTRON https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103949s5299lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103949Orig1s5299ltr.pdf
05/13/2015 SUPPL-5298 Supplement Label (PDF)
Letter (PDF)
Label for SYLATRON https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103949s5298lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103949Orig1s5298ltr.pdf
05/21/2015 SUPPL-5297 Supplement Label (PDF)
Letter (PDF)
Label for PEGINTRON https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103949s5297lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103949Orig1s5297ltr.pdf
10/09/2014 SUPPL-5296 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5296ltr.pdf
07/31/2014 SUPPL-5295 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5295lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5295ltr.pdf
11/17/2014 SUPPL-5293 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5293lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5293ltr.pdf
08/11/2014 SUPPL-5288 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5288lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5288ltr.pdf
08/30/2014 SUPPL-5287 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5287lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5287ltr.pdf
08/14/2014 SUPPL-5285 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5285lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103949Orig1s5285ltr.pdf
11/15/2013 SUPPL-5273 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103949s5273lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103949Orig1s5273ltr.pdf
05/15/2013 SUPPL-5263 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103949s5263lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103949Orig1s5263ltr.pdf
12/18/2013 SUPPL-5259 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103949s5259lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103949Orig1s5259ltr.pdf
12/26/2012 SUPPL-5252 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103949s5252lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103949Orig1s5252ltr.pdf
12/09/2013 SUPPL-5248 Supplement

Label is not available on this site.

07/02/2012 SUPPL-5232 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103949s5232lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103949s5232ltr.pdf
06/04/2012 SUPPL-5231 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103949s5231ltr.pdf
12/22/2011 SUPPL-5222 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5217s5222lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5217,s5222ltr.pdf
12/22/2011 SUPPL-5217 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5217s5222lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5217,s5222ltr.pdf
05/13/2011 SUPPL-5211 Supplement

Label is not available on this site.

06/06/2011 SUPPL-5204 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5204lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5204ltr.pdf
05/06/2011 SUPPL-5203 Supplement

Label is not available on this site.

02/01/2011 SUPPL-5201 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5201ltr.pdf
07/21/2010 SUPPL-5199 Supplement

Label is not available on this site.

01/26/2010 SUPPL-5184 Supplement

Label is not available on this site.

08/07/2009 SUPPL-5183 Supplement

Label is not available on this site.

05/08/2009 SUPPL-5175 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103949s5175ltr.pdf
12/11/2008 SUPPL-5174 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103949s5171, s5174lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103949s5171, s5174ltr.pdf
05/08/2009 SUPPL-5172 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103949s5172lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103949s5172ltr.pdf
12/11/2008 SUPPL-5171 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103949s5171, s5174lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103949s5171, s5174ltr.pdf
03/29/2011 SUPPL-5153 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5153lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103949s5153ltr.pdf
05/31/2007 SUPPL-5135 Supplement

Label is not available on this site.

03/10/2009 SUPPL-5125 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103949s5125lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103949s5125ltr.pdf
12/22/2006 SUPPL-5124 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103949s5124LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103949s5124LTR.pdf
03/26/2008 SUPPL-5123 Supplement

Label is not available on this site.

10/10/2006 SUPPL-5118 Supplement

Label is not available on this site.

07/22/2005 SUPPL-5105 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103949_5105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103949_5105ltr.pdf
05/04/2005 SUPPL-5099 Supplement

Label is not available on this site.

10/15/2004 SUPPL-5088 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103949_5088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103949_5088ltr.pdf
10/15/2004 SUPPL-5087 Supplement

Label is not available on this site.

10/01/2004 SUPPL-5086 Supplement

Label is not available on this site.

11/03/2005 SUPPL-5077 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103949s5077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103949s5077ltr.pdf
03/05/2004 SUPPL-5070 Supplement

Label is not available on this site.

09/23/2004 SUPPL-5061 Supplement

Label is not available on this site.

03/14/2003 SUPPL-5041 Supplement

Label is not available on this site.

07/17/2002 SUPPL-5032 Supplement

Label is not available on this site.

11/21/2002 SUPPL-5030 Supplement

Label is not available on this site.

08/07/2001 SUPPL-5002 Supplement Label
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/pegsche080701LB.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/pegsche080701L.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/103949s5002_PEGIntronTOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/25/2017 SUPPL-5304 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103949s5304lbl.pdf
09/16/2015 SUPPL-5299 Labeling-Package Insert Label (PDF) Label for PEGINTRON https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103949s5299lbl.pdf
05/21/2015 SUPPL-5297 Labeling-Package Insert Label (PDF) Label for PEGINTRON https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103949s5297lbl.pdf
05/13/2015 SUPPL-5298 Labeling-Medication Guide Label (PDF) Label for SYLATRON https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103949s5298lbl.pdf
05/13/2015 SUPPL-5298 Labeling-Package Insert Label (PDF) Label for SYLATRON https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103949s5298lbl.pdf
11/17/2014 SUPPL-5293 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5293lbl.pdf
08/30/2014 SUPPL-5287 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5287lbl.pdf
08/14/2014 SUPPL-5285 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5285lbl.pdf
08/11/2014 SUPPL-5288 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5288lbl.pdf
07/31/2014 SUPPL-5295 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103949s5295lbl.pdf
12/18/2013 SUPPL-5259 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103949s5259lbl.pdf
11/15/2013 SUPPL-5273 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103949s5273lbl.pdf
05/15/2013 SUPPL-5263 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103949s5263lbl.pdf
12/26/2012 SUPPL-5252 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103949s5252lbl.pdf
07/02/2012 SUPPL-5232 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103949s5232lbl.pdf
12/22/2011 SUPPL-5222 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5217s5222lbl.pdf
12/22/2011 SUPPL-5217 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5217s5222lbl.pdf
06/06/2011 SUPPL-5204 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5204lbl.pdf
03/29/2011 SUPPL-5153 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103949s5153lbl.pdf
05/08/2009 SUPPL-5172 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103949s5172lbl.pdf
03/10/2009 SUPPL-5125 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103949s5125lbl.pdf
12/11/2008 SUPPL-5174 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103949s5171, s5174lbl.pdf
12/11/2008 SUPPL-5171 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103949s5171, s5174lbl.pdf
12/22/2006 SUPPL-5124 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103949s5124LBL.pdf
11/03/2005 SUPPL-5077 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103949s5077lbl.pdf
07/22/2005 SUPPL-5105 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103949_5105lbl.pdf
10/15/2004 SUPPL-5088 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103949_5088lbl.pdf
08/07/2001 SUPPL-5002 Efficacy https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/pegsche080701LB.htm
01/19/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/pegsche011901LB.PDF

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