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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 Dow Pharm 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. Five suppliers are listed for this compound. Additional details are available on the methoxsalen profile page.

Summary for NDA: 019600

Dow Pharm
Therapeutic Class:Dermatological Agents

Pharmacology for NDA: 019600

Mechanism of ActionPhotoabsorption
Physiological EffectPhotosensitizing Activity

Suppliers and Packaging for NDA: 019600

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 019600 NDA Valeant Pharmaceuticals North America LLC 0187-0650 0187-0650-42 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0187-0650-42)
CAPSULE;ORAL 019600 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-065 68682-065-10 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68682-065-10)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 019600

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Dow Pharm
CAPSULE;ORAL019600-001Oct 30, 19864,454,152► subscribe
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