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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 two suppliers. There are four patents protecting this drug. Additional details are available on the CYSVIEW KIT profile page.

The generic ingredient in CYSVIEW KIT is hexaminolevulinate hydrochloride. Two suppliers are listed for this compound. Additional details are available on the hexaminolevulinate hydrochloride profile page.

Summary for NDA: 022555

Tradename:
CYSVIEW KIT
Applicant:
Photocure Asa
Ingredient:
hexaminolevulinate hydrochloride
Patents:4

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 GE Healthcare Inc. 0407-4086 0407-4086-01 1 KIT in 1 CARTON (0407-4086-01) * 50 mL in 1 VIAL, GLASS (0407-4085-01) * 50 mL in 1 VIAL
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;INTRAVESICALStrength100MG/VIAL
Approval Date:May 28, 2010TE:RLD:Yes
Patent:6,034,267Patent Expiration:Mar 8, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:DETECTION OF NON-MUSCLE INVASIVE PAPILLARY CANCER OF THE BLADDER BY PHOTODYNAMIC CYSTOSCOPY
Patent:7,247,655Patent Expiration:Mar 8, 2016Product Flag?YSubstance Flag?Delist Request?
Patented Use:DETECTION OF NON-MUSCLE INVASIVE PAPILLARY CANCER OF THE BLADDER BY PHOTODYNAMIC CYSTOSCOPY
Patent:7,348,361Patent 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 Orange Book Patents for NDA: 022555

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Photocure Asa
CYSVIEW KIT
hexaminolevulinate hydrochloride
FOR SOLUTION;INTRAVESICAL022555-001May 28, 20106,034,267► subscribe
Photocure Asa
CYSVIEW KIT
hexaminolevulinate hydrochloride
FOR SOLUTION;INTRAVESICAL022555-001May 28, 20107,247,655► subscribe
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