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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 are five 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. Two suppliers are listed for this compound. Additional details are available on the aminolevulinic acid hydrochloride profile page.

Summary for NDA: 020965

Tradename:
LEVULAN
Applicant:
Dusa
Ingredient:
aminolevulinic acid hydrochloride
Patents:5
Formulation / Manufacturing:see details

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 67308-101-02 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
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL 020965 NDA DUSA Pharmaceuticals, Inc. 67308-101 67308-101-06 6 APPLICATOR in 1 CARTON (67308-101-06) > 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength20%
Approval Date:Dec 3, 1999TE:RLD:Yes
Patent:5,954,703Patent Expiration:Oct 31, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
Patent:6,709,446Patent Expiration:May 1, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
Patent:7,723,910Patent Expiration:Jun 17, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP

Expired Orange Book Patents for NDA: 020965

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 19995,079,262► subscribe
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 19996,710,066► subscribe
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 19995,422,093► subscribe
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