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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208081

AMELUZ (AMINOLEVULINIC ACID HYDROCHLORIDE)
10%
Marketing Status: Prescription
Active Ingredient: AMINOLEVULINIC ACID HYDROCHLORIDE
Proprietary Name: AMELUZ
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 10%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208081
Product Number: 001
Approval Date: May 10, 2016
Applicant Holder Full Name: BIOFRONTERA BIOSCIENCE GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
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