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Last Updated: June 17, 2021

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Details for New Drug Application (NDA): 019600

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NDA 019600 describes OXSORALEN-ULTRA, which is a drug marketed by Bausch and is included in one NDA. It is available from two suppliers. Additional details are available on the OXSORALEN-ULTRA profile page.

The generic ingredient in OXSORALEN-ULTRA is methoxsalen. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methoxsalen profile page.
Summary for 019600
Formulation / Manufacturing:see details
Pharmacology for NDA: 019600
Mechanism of ActionPhotoabsorption
Physiological EffectPhotosensitizing Activity
Medical Subject Heading (MeSH) Categories for 019600
Suppliers and Packaging for NDA: 019600
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXSORALEN-ULTRA methoxsalen CAPSULE;ORAL 019600 NDA Bausch Health US, LLC 0187-0650 0187-0650-42 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0187-0650-42)
OXSORALEN-ULTRA methoxsalen CAPSULE;ORAL 019600 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-065 68682-065-10 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68682-065-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Oct 30, 1986TE:ABRLD:Yes

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts

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