Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208630

GLEOLAN (AMINOLEVULINIC ACID HYDROCHLORIDE)
1.5GM/VIAL Marketing Status: Prescription

Active Ingredient: AMINOLEVULINIC ACID HYDROCHLORIDE
Proprietary Name: GLEOLAN
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: 1.5GM/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208630
Product Number: 001
Approval Date: Jun 6, 2017
Applicant Holder Full Name: NX DEVELOPMENT CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

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