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Generated: November 18, 2018

DrugPatentWatch Database Preview

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 are four patents 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. Three 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:4
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:➤ Sign UpPatent Expiration:May 1, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
Patent:➤ Sign UpPatent Expiration:Jun 17, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP

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

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
AstraZeneca
Deloitte
McKinsey
Argus Health
Federal Trade Commission
Teva
Cipla
Medtronic

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