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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022555

CYSVIEW KIT (HEXAMINOLEVULINATE HYDROCHLORIDE)
100MG/VIAL
Marketing Status: Prescription
Active Ingredient: HEXAMINOLEVULINATE HYDROCHLORIDE
Proprietary Name: CYSVIEW KIT
Dosage Form; Route of Administration: FOR SOLUTION; INTRAVESICAL
Strength: 100MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022555
Product Number: 001
Approval Date: May 28, 2010
Applicant Holder Full Name: PHOTOCURE ASA
Marketing Status:  Prescription
Patent and Exclusivity Information
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