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Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018327

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NDA 018327 describes XENON XE 133, which is a drug marketed by Ge Healthcare, Gen Electric, Lantheus Medcl, and Mallinkrodt Nuclear, and is included in six NDAs. It is available from two suppliers. Additional details are available on the XENON XE 133 profile page.

The generic ingredient in XENON XE 133 is xenon xe-133. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the xenon xe-133 profile page.
Summary for 018327
Tradename:XENON XE 133
Applicant:Mallinkrodt Nuclear
Ingredient:xenon xe-133
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018327
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 018327
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XENON XE 133 xenon xe-133 GAS;INHALATION 018327 NDA MALLINCKRODT NUCLEAR MEDICINE LLC 69945-097 69945-097-11 1 CAN in 1 CONTAINER (69945-097-11) > 1 BOTTLE in 1 CAN > 2 mL in 1 BOTTLE
XENON XE 133 xenon xe-133 GAS;INHALATION 018327 NDA MALLINCKRODT NUCLEAR MEDICINE LLC 69945-097 69945-097-13 3 CAN in 1 CONTAINER (69945-097-13) > 1 BOTTLE in 1 CAN > 2 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GAS;INHALATIONStrength10mCi/VIAL
Approval Date:Mar 9, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GAS;INHALATIONStrength20mCi/VIAL
Approval Date:Mar 9, 1982TE:RLD:No

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