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Last Updated: July 8, 2020

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Details for New Drug Application (NDA): 020965


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NDA 020965 describes LEVULAN, which is a drug marketed by Dusa 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 LEVULAN profile page.

The generic ingredient in LEVULAN is aminolevulinic acid hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the aminolevulinic acid hydrochloride profile page.
Summary for 020965
Tradename:LEVULAN
Applicant:Dusa
Ingredient:aminolevulinic acid hydrochloride
Patents:1
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020965
Suppliers and Packaging for NDA: 020965
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965 NDA DUSA Pharmaceuticals, Inc. 67308-101 67308-101-01 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE
LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965 NDA DUSA Pharmaceuticals, Inc. 67308-101 67308-101-02 2 APPLICATOR in 1 CARTON (67308-101-02) > 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength20%
Approval Date:Dec 3, 1999TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 9, 2021
Regulatory Exclusivity Use:TREATMENT OF MINIMALLY TO MODERATELY THICK ACTINIC KERATOSIS OF THE UPPER EXTREMITIES IN CONJUNCTION WITH A BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
Patent:  Start TrialPatent Expiration:Jan 12, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACTINIC KERATOSES BY PHOTODYNAMIC THERAPY

Expired US Patents for NDA 020965

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999   Start Trial   Start Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999   Start Trial   Start Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Boehringer Ingelheim

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