Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103132
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INTRON A INTERFERON ALFA-2B 10MIU/VIAL VIAL Prescription None No No
INTRON A INTERFERON ALFA-2B 18MIU/VIAL VIAL Prescription None No No
INTRON A INTERFERON ALFA-2B 25MIU/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
06/04/1986 ORIG-1 Approval N/A Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/103132Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/04/2018 SUPPL-5199 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103132Orig1s5199lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103132Orig1s5199ltr.pdf
10/02/2017 SUPPL-5196 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5196lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103132Orig1s5196ltr.pdf
06/12/2017 SUPPL-5195 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5195lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103132Orig1s5195ltr.pdf
05/21/2015 SUPPL-5191 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103132s5191lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103132Orig1s5191ltr.pdf
08/11/2014 SUPPL-5190 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103132s5190lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103132Origs5190ltr.pdf
04/02/2014 SUPPL-5183 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103132s5183lbl.pdf
11/15/2013 SUPPL-5178 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103132s5178lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103132Orig1s5178ltr.pdf
06/04/2012 SUPPL-5163 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103132s5163ltr.pdf
12/20/2011 SUPPL-5161 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103132s5161lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103132s5161ltr.pdf
05/13/2011 SUPPL-5153 Supplement

Label is not available on this site.

06/06/2011 SUPPL-5148 Supplement

Label is not available on this site.

02/01/2011 SUPPL-5143 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103132s5143ltr.pdf
07/21/2010 SUPPL-5140 Supplement

Label is not available on this site.

08/07/2009 SUPPL-5122 Supplement

Label is not available on this site.

02/16/2010 SUPPL-5118 Supplement

Label is not available on this site.

05/02/2008 SUPPL-5108 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103132s5108ltr.pdf
07/13/2007 SUPPL-5096 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103132s5096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103132s5096ltr.pdf
05/22/2007 SUPPL-5095 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103132s5095lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103132s5095ltr.pdf
07/28/2006 SUPPL-5086 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103132s5086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103132s5086ltr.pdf
10/27/2004 SUPPL-5064 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103132_5064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103132_5064ltr.pdf
05/22/2007 SUPPL-5059 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103132s5095ltr.pdf
06/21/2002 SUPPL-5022 Supplement

Label is not available on this site.

11/26/2003 SUPPL-5018 Supplement

Label is not available on this site.

11/29/2001 SUPPL-5016 Supplement

Label is not available on this site.

11/29/2001 SUPPL-5009 Supplement

Label is not available on this site.

02/01/2002 SUPPL-5006 Supplement

Label is not available on this site.

06/21/2001 SUPPL-1144 Supplement

Label is not available on this site.

08/18/1998 SUPPL-1127 Supplement

Label is not available on this site.

04/29/1997 SUPPL-1120 Supplement

Label is not available on this site.

11/06/1997 SUPPL-1116 Supplement Label (PDF)
Letter
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/ifnasch110697-lab.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/ifnasch110697L.htm https://www.accessdata.fda.gov/drugsatfda_docs/bla/1997/ifnasch110697r.pdf
03/26/1997 SUPPL-1107 Supplement

Label is not available on this site.

12/05/1995 SUPPL-1096 Supplement

Label is not available on this site.

05/14/1993 SUPPL-1040 Supplement

Label is not available on this site.

07/13/1992 SUPPL-1030 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/04/2018 SUPPL-5199 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103132Orig1s5199lbl.pdf
10/02/2017 SUPPL-5196 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5196lbl.pdf
10/02/2017 SUPPL-5196 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5196lbl.pdf
06/12/2017 SUPPL-5195 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5195lbl.pdf
05/21/2015 SUPPL-5191 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103132s5191lbl.pdf
05/21/2015 SUPPL-5191 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103132s5191lbl.pdf
08/11/2014 SUPPL-5190 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103132s5190lbl.pdf
04/02/2014 SUPPL-5183 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103132s5183lbl.pdf
11/15/2013 SUPPL-5178 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103132s5178lbl.pdf
12/20/2011 SUPPL-5161 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103132s5161lbl.pdf
07/13/2007 SUPPL-5096 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103132s5096lbl.pdf
05/22/2007 SUPPL-5095 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103132s5095lbl.pdf
07/28/2006 SUPPL-5086 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103132s5086lbl.pdf
10/27/2004 SUPPL-5064 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103132_5064lbl.pdf
11/06/1997 SUPPL-1116 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/ifnasch110697-lab.pdf

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