Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103780
Company: SERONO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REBIF INTERFERON BETA-1A 22UG/0.5ML SYRINGE Prescription None No No
REBIF INTERFERON BETA-1A 44UG/0.5ML 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
03/07/2002 ORIG-1 Approval N/A Label (PDF)
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ifnbser030702LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ifnbser030702L.htm https://web.archive.org/web/20170118085129/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080737.htm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/27/2016 SUPPL-5196 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103780s5196lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103780Orig1s5196ltr.pdf
12/22/2015 SUPPL-5194 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103780s5194lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103780Orig1s5194ltr.pdf
04/24/2014 SUPPL-5179 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103780s5178s5179lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103780Orig1s5178,s5179ltr.pdf
04/24/2014 SUPPL-5178 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103780s5178s5179lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103780Orig1s5178,s5179ltr.pdf
03/10/2015 SUPPL-5172 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103780s5172lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103780Orig1s5172ltr.pdf
04/19/2013 SUPPL-5140 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103780s5140lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103780Orig1s5140ltr.pdf
12/21/2012 SUPPL-5121 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103780s5121lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103780Orig1s5121ltr.pdf
06/30/2005 SUPPL-5062 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103780s5062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103780s5062ltr.pdf
12/17/2004 SUPPL-5052 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103780_5052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103780_5052ltr.pdf
12/23/2004 SUPPL-5030 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103780_5030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103780_5030ltr.pdf
03/26/2004 SUPPL-5027 Supplement

Label is not available on this site.

05/02/2003 SUPPL-5010 Supplement Label (PDF)
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbser050203LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbser050203L.htm https://web.archive.org/web/20120303004314/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080739.htm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/27/2016 SUPPL-5196 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103780s5196lbl.pdf
12/22/2015 SUPPL-5194 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103780s5194lbl.pdf
03/10/2015 SUPPL-5172 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103780s5172lbl.pdf
04/24/2014 SUPPL-5179 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103780s5178s5179lbl.pdf
04/24/2014 SUPPL-5178 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103780s5178s5179lbl.pdf
04/19/2013 SUPPL-5140 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103780s5140lbl.pdf
12/21/2012 SUPPL-5121 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103780s5121lbl.pdf
06/30/2005 SUPPL-5062 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103780s5062lbl.pdf
12/23/2004 SUPPL-5030 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103780_5030lbl.pdf
12/17/2004 SUPPL-5052 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103780_5052lbl.pdf
05/02/2003 SUPPL-5010 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbser050203LB.pdf
03/07/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ifnbser030702LB.pdf

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