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Generated: November 19, 2018

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Details for New Drug Application (NDA): 020969

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NDA 020969 describes UVADEX, which is a drug marketed by Mallinckrodt Hosp and is included in one NDA. It is available from one supplier. Additional details are available on the UVADEX profile page.

The generic ingredient in UVADEX is methoxsalen. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the methoxsalen profile page.
Summary for 020969
Tradename:UVADEX
Applicant:Mallinckrodt Hosp
Ingredient:methoxsalen
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020969
Ingredient-typePsoralens
Mechanism of ActionPhotoabsorption
Physiological EffectPhotosensitizing Activity
Medical Subject Heading (MeSH) Categories for 020969
Suppliers and Packaging for NDA: 020969
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
UVADEX methoxsalen INJECTABLE;INJECTION 020969 NDA Therakos, Inc. 64067-216 64067-216-01 12 VIAL, GLASS in 1 CARTON (64067-216-01) > 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.02MG/ML
Approval Date:Feb 25, 1999TE:RLD:Yes

Expired US Patents for NDA 020969

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Hosp UVADEX methoxsalen INJECTABLE;INJECTION 020969-001 Feb 25, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Mallinckrodt Hosp UVADEX methoxsalen INJECTABLE;INJECTION 020969-001 Feb 25, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Mallinckrodt Hosp UVADEX methoxsalen INJECTABLE;INJECTION 020969-001 Feb 25, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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