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Generated: November 16, 2018

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Details for New Drug Application (NDA): 022555

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NDA 022555 describes CYSVIEW KIT, which is a drug marketed by Photocure Asa and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the CYSVIEW KIT profile page.

The generic ingredient in CYSVIEW KIT is hexaminolevulinate hydrochloride. One supplier is listed for this compound. Additional details are available on the hexaminolevulinate hydrochloride profile page.
Summary for 022555
Tradename:CYSVIEW KIT
Applicant:Photocure Asa
Ingredient:hexaminolevulinate hydrochloride
Patents:1
Generic Entry Opportunity Date for 022555
Generic Entry Date for 022555*:
Constraining patent/regulatory exclusivity:
ADDITIONAL INFORMATION ADDED TO THE LABELING FROM STUDY PC B308/13 REGARDING THE USE OF BLUE LIGHT CYSTOSCOPY WITH CYSVIEW AS AN ADJUNCT TO WHITE LIGHT CYSTOSCOPY
Dosage:
FOR SOLUTION;INTRAVESICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 022555
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYSVIEW KIT hexaminolevulinate hydrochloride FOR SOLUTION;INTRAVESICAL 022555 NDA Photocure ASA 10511-3001 10511-3001-2 1 KIT in 1 CARTON (10511-3001-2) * 50 mL in 1 SYRINGE, PLASTIC * 50 mL in 1 VIAL, GLASS
CYSVIEW KIT hexaminolevulinate hydrochloride FOR SOLUTION;INTRAVESICAL 022555 NDA Photocure ASA 10511-3001 10511-3001-1 1 KIT in 1 CARTON (10511-3001-1) * 50 mL in 1 VIAL, GLASS * 50 mL in 1 VIAL, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;INTRAVESICALStrength100MG/VIAL
Approval Date:May 28, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 15, 2021
Regulatory Exclusivity Use:ADDITIONAL INFORMATION ADDED TO THE LABELING FROM STUDY PC B308/13 REGARDING THE USE OF BLUE LIGHT CYSTOSCOPY WITH CYSVIEW AS AN ADJUNCT TO WHITE LIGHT CYSTOSCOPY
Patent:➤ Sign UpPatent Expiration:Nov 6, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:DETECTION OF CARCINOMA IN THE BLADDER BY PHOTODYNAMIC CYSTOSCOPY
Patent:➤ Sign UpPatent Expiration:Nov 6, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:DETECTION OF NON-MUSCLE INVASIVE PAPILLARY CANCER OF THE BLADDER BY PHOTODYNAMIC CYSTOSCOPY

Expired US Patents for NDA 022555

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Photocure Asa CYSVIEW KIT hexaminolevulinate hydrochloride FOR SOLUTION;INTRAVESICAL 022555-001 May 28, 2010 ➤ Sign Up ➤ Sign Up
Photocure Asa CYSVIEW KIT hexaminolevulinate hydrochloride FOR SOLUTION;INTRAVESICAL 022555-001 May 28, 2010 ➤ Sign Up ➤ Sign Up
Photocure Asa CYSVIEW KIT hexaminolevulinate hydrochloride FOR SOLUTION;INTRAVESICAL 022555-001 May 28, 2010 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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