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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022555
Company: PHOTOCURE ASA

Summary Review

Products on NDA 022555

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYSVIEW KIT	HEXAMINOLEVULINATE HYDROCHLORIDE	100MG/VIAL	FOR SOLUTION;INTRAVESICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022555

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2010	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022555s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022555s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022555_cysview_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022555Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2018	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022555s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022555Orig1s005ltr.pdf
07/29/2016	SUPPL-4	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022555s004lbl.pdf
11/28/2012	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022555

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2018	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022555s005lbl.pdf
07/29/2016	SUPPL-4	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022555s004lbl.pdf
05/28/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022555s000lbl.pdf

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