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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021119
Company: VALEANT LUXEMBOURG

Products on NDA 021119

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VISUDYNE	VERTEPORFIN	15MG/VIAL	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021119

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
02/12/2023	SUPPL-34	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021119s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021119Orig1s034ltr.pdf
07/09/2021	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021119s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021119Orig1s029ltr.pdf
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

Labels for NDA 021119

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/12/2023	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021119s034lbl.pdf
02/12/2023	SUPPL-34	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021119s034lbl.pdf
07/09/2021	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021119s029lbl.pdf
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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