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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
UBS
Colorcon
Fuji
McKesson
Harvard Business School
Federal Trade Commission
Daiichi Sankyo
Express Scripts

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208081

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NDA 208081 describes AMELUZ, which is a drug marketed by Biofrontera 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 AMELUZ profile page.

The generic ingredient in AMELUZ is aminolevulinic acid hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aminolevulinic acid hydrochloride profile page.
Summary for 208081
Tradename:AMELUZ
Applicant:Biofrontera
Ingredient:aminolevulinic acid hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 208081
Ingredient-typePorphyrinogens
Medical Subject Heading (MeSH) Categories for 208081
Suppliers and Packaging for NDA: 208081
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMELUZ aminolevulinic acid hydrochloride GEL;TOPICAL 208081 NDA Biofrontera Inc. 70621-101 N 70621-101-01
AMELUZ aminolevulinic acid hydrochloride GEL;TOPICAL 208081 NDA Biofrontera Inc. 70621-101 N 70621-101-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength10%
Approval Date:May 10, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:May 10, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:Nov 12, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACTINIC KERATOSES BY PHOTODYNAMIC THERAPY

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Deloitte
Healthtrust
Federal Trade Commission
Mallinckrodt
Express Scripts
McKinsey
US Army
Cantor Fitzgerald

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