Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103950
Company: BIOVITRUM AB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KINERET ANAKINRA 10MIU/VIAL VIAL; SUBCUTANEOUS Prescription None No No
KINERET ANAKINRA 18MIU/VIAL VIAL; SUBCUTANEOUS Prescription None No No
KINERET ANAKINRA 25MIU/VIAL VIAL; SUBCUTANEOUS 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
11/14/2001 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter
Patient Package Insert (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/anakamg111401LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/anakamg111401L.htm https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/anakamg111401ptLB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/103950-0_Kineret.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2018 SUPPL-5182 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103950s5182lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103950Orig1s5182ltr.pdf
05/19/2016 SUPPL-5175 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103950s5175lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103950Orig1s5175ltr.pdf
10/23/2013 SUPPL-5150 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103950s5150lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103950Orig1s5150ltr.pdf
12/21/2012 SUPPL-5136 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103950s5136lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103950Orig1s5136ltr.pdf
09/23/2011 SUPPL-5116 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103950s5116lbl.pdf
10/31/2008 SUPPL-5079 Supplement

Label is not available on this site.

12/15/2006 SUPPL-5064 Supplement

Label is not available on this site.

02/22/2006 SUPPL-5061 Supplement

Label is not available on this site.

08/09/2005 SUPPL-5058 Supplement

Label is not available on this site.

04/23/2004 SUPPL-5039 Supplement Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103950s5039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103950_5039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103950s5039ppi.pdf
08/22/2003 SUPPL-5019 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103950-5019ltr.pdf
06/27/2003 SUPPL-5013 Supplement Label (PDF)
Letter
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/anakamg062703LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/anakamg062703L.htm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/07/2018 SUPPL-5182 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103950s5182lbl.pdf
05/19/2016 SUPPL-5175 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103950s5175lbl.pdf
10/23/2013 SUPPL-5150 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103950s5150lbl.pdf
12/21/2012 SUPPL-5136 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103950s5136lbl.pdf
09/23/2011 SUPPL-5116 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103950s5116lbl.pdf
04/23/2004 SUPPL-5039 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103950s5039lbl.pdf
06/27/2003 SUPPL-5013 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/anakamg062703LB.pdf
11/14/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/anakamg111401LB.pdf

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