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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103770
Company: SWEDISH ORPHAN

In-use labeling as of 11/30/2022

Products on BLA 103770

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103770

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
07/23/2004	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

Labels for BLA 103770

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
07/23/2004	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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