Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103770
Company: SWEDISH ORPHAN
Company: SWEDISH ORPHAN
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 | |
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 |
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 |