Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021119
Company: VALEANT LUXEMBOURG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VISUDYNE VERTEPORFIN 15MG/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/12/2000 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21119lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21119ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-119_Visudyne.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/11/2016 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021119s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021119Orig1s027ltr.pdf
05/06/2014 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/08/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/28/2012 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021119s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021119s022ltr.pdf
03/28/2007 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021119s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021119s021ltr.pdf
06/30/2008 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021119s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021119se8-013ltr.pdf
03/25/2005 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21119s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21119s012ltr.pdf
02/12/2004 SUPPL-10 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21119slr006,scp010ltr.pdf
02/12/2004 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21119slr006,scp010ltr.pdf
11/25/2002 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119slr005_visudyne_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21119slr005ltr.pdf
05/29/2002 SUPPL-4 Manufacturing (CMC) Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21119s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-119s004_Visudyne.cfm
04/30/2002 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21119s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-119s003_Visudyne.cfm
02/15/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/22/2001 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21119s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21119s1ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-119S001_Visudyne.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/11/2016 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021119s027lbl.pdf
06/28/2012 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021119s022lbl.pdf
06/30/2008 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021119s013lbl.pdf
03/28/2007 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021119s021lbl.pdf
03/25/2005 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21119s012lbl.pdf
11/25/2002 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119slr005_visudyne_lbl.pdf
05/29/2002 SUPPL-4 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119s4lbl.pdf
04/30/2002 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119s3lbl.pdf
08/22/2001 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21119s1lbl.pdf
04/12/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21119lbl.pdf

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