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Details for New Drug Application (NDA): 009048

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NDA 009048 describes OXSORALEN, which is a drug marketed by Valeant Pharm Intl and Dow Pharm and is included in two NDAs. It is available from one supplier. Additional details are available on the OXSORALEN profile page.

The generic ingredient in OXSORALEN 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: 009048

Tradename:
8-MOP
Applicant:
Valeant Pharm Intl
Ingredient:
methoxsalen
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 009048

Ingredient-typePsoralens
Mechanism of ActionPhotoabsorption
Physiological EffectPhotosensitizing Activity

Suppliers and Packaging for NDA: 009048

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
8-MOP
methoxsalen
CAPSULE;ORAL 009048 NDA Valeant Pharmaceuticals North America LLC 0187-0651 0187-0651-42 50 CAPSULE, GELATIN COATED in 1 BOTTLE, GLASS (0187-0651-42)
OXSORALEN
methoxsalen
LOTION;TOPICAL 009048 NDA Valeant Pharmaceuticals North America LLC 0187-0651 0187-0651-42 50 CAPSULE, GELATIN COATED in 1 BOTTLE, GLASS (0187-0651-42)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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