Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103770
Company: MEDIMMUNE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYNAGIS PALIVIZUMAB 100MG/VIAL VIAL Prescription None No No
SYNAGIS PALIVIZUMAB 50MG/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
06/19/1998 ORIG-1 Approval N/A Letter
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/palimed061998L.htm https://web.archive.org/web/20160723194308/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093366.htm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/12/2017 SUPPL-5200 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103770s5200lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103770Orig1s5200ltr.pdf
03/21/2014 SUPPL-5185 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103770s5185lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103770Orig1s5185ltr.pdf
04/04/2012 SUPPL-5161 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103770s5161lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103770s5161ltr.pdf
04/04/2011 SUPPL-5153 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103770s5153ltr.pdf
03/23/2009 SUPPL-5116 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103770s5116lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103770s5116ltr.pdf
08/01/2008 SUPPL-5113 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103770s5113lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103770s5113ltr.pdf
02/28/2007 SUPPL-5096 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103770_5096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103770_5096LTR.pdf
12/14/2004 SUPPL-5059 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103770_s5059_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103770_s5059_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2004/103770Orig1s5059.pdf
09/15/2003 SUPPL-5033 Supplement Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/bla/2003/103770Orig1s5033.pdf
10/23/2002 SUPPL-5022 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/palimed102302LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/palimed102302L.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/12/2017 SUPPL-5200 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103770s5200lbl.pdf
03/21/2014 SUPPL-5185 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103770s5185lbl.pdf
04/04/2012 SUPPL-5161 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103770s5161lbl.pdf
03/23/2009 SUPPL-5116 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103770s5116lbl.pdf
08/01/2008 SUPPL-5113 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103770s5113lbl.pdf
02/28/2007 SUPPL-5096 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103770_5096lbl.pdf
12/14/2004 SUPPL-5059 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103770_s5059_lbl.pdf
10/23/2002 SUPPL-5022 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/palimed102302LB.pdf

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