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Generated: April 23, 2017

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Details for New Drug Application (NDA): 018327

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NDA 018327 describes XENON XE 133, which is a drug marketed by Mallinkrodt Nuclear, Gen Electric, Ge Healthcare, and Lantheus Medcl, 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 eleven 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 NDA: 018327


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
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
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

Summary for product number 001

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

Summary for product number 002

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

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