Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103949
Company: SCHERING
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 |
Label for PEGINTRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/pegsche011901LB.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/pegsche011901L.htm https://web.archive.org/web/20160402193205/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 |
|---|---|---|---|---|---|
| 01/08/2019 | SUPPL-5313 | Supplement |
Label (PDF)
Letter (PDF) |
Label for PEGINTRON; Medication Guide for PEGINTRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103949s5313lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103949Orig1s5313ltr.pdf |
| 12/21/2018 | SUPPL-5312 | Supplement |
Label (PDF)
Letter (PDF) |
Label for SYLATRON; Medication Guide for SYLATRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5312lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103949Orig1s5312Ltr.pdf |
| 05/25/2018 | SUPPL-5311 | Supplement |
Label (PDF)
Letter (PDF) |
Label for PEGINTRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5311lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103949Orig1s5311ltr.pdf |
| 05/04/2018 | SUPPL-5310 | Supplement |
Label (PDF)
Letter (PDF) |
Label for SYLATRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949Orig1s5310lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103949Orig1s5310ltr.pdf |
| 10/02/2017 | SUPPL-5307 | Supplement |
Label (PDF)
Letter (PDF) |
Label for SYLATRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103949s5305s5307lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103949Orig1s5305s5307ltr.pdf |
| 10/03/2017 | SUPPL-5306 | Supplement |
Label (PDF)
Letter (PDF) |
Label for PEGINTRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103949s5306lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103949Orig1s5306ltr.pdf |
| 10/02/2017 | SUPPL-5305 | Supplement |
Label (PDF)
Letter (PDF) |
Label for SYLATRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103949s5305s5307lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103949Orig1s5305s5307ltr.pdf |
| 05/25/2017 | SUPPL-5304 | Supplement |
Label (PDF)
Letter (PDF) |
Label for PEGINTRON | 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 |
Letter (PDF)
|
Label for SYLATRON
Label is not available on this site. |
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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103949s5259lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103949Orig1s5259ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/103949Orig1s5259.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 |
|---|---|---|---|---|---|
| 01/08/2019 | SUPPL-5313 | Labeling-Package Insert | Label (PDF) | Label for PEGINTRON; Medication Guide for PEGINTRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103949s5313lbl.pdf |
| 12/21/2018 | SUPPL-5312 | Labeling-Package Insert | Label (PDF) | Label for SYLATRON; Medication Guide for SYLATRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5312lbl.pdf |
| 05/25/2018 | SUPPL-5311 | Labeling-Package Insert | Label (PDF) | Label for PEGINTRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5311lbl.pdf |
| 05/04/2018 | SUPPL-5310 | Labeling-Package Insert | Label (PDF) | Label for SYLATRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949Orig1s5310lbl.pdf |
| 10/03/2017 | SUPPL-5306 | Labeling-Medication Guide | Label (PDF) | Label for PEGINTRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103949s5306lbl.pdf |
| 10/03/2017 | SUPPL-5306 | Labeling-Package Insert | Label (PDF) | Label for PEGINTRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103949s5306lbl.pdf |
| 10/02/2017 | SUPPL-5307 | Labeling-Package Insert | Label (PDF) | Label for SYLATRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103949s5305s5307lbl.pdf |
| 10/02/2017 | SUPPL-5305 | Labeling-Medication Guide | Label (PDF) | Label for SYLATRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103949s5305s5307lbl.pdf |
| 10/02/2017 | SUPPL-5305 | Labeling-Package Insert | Label (PDF) | Label for SYLATRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103949s5305s5307lbl.pdf |
| 05/25/2017 | SUPPL-5304 | Labeling-Package Insert | Label (PDF) | Label for PEGINTRON | 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 |
| 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) | Label for PEGINTRON | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/pegsche011901LB.PDF |