Details for New Drug Application (NDA): 018327
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NDA 018327 describes XENON XE 133, which is a drug marketed by Curium, Ge Healthcare, Gen Electric, 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 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.
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: | Curium |
| Ingredient: | xenon xe-133 |
| Patents: | 0 |
Pharmacology for NDA: 018327
| Mechanism of Action | Radiopharmaceutical 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 | Curium US 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 | Curium US 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: | RX | Dosage: | GAS;INHALATION | Strength | 10mCi/VIAL | ||||
| Approval Date: | Mar 9, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | GAS;INHALATION | Strength | 20mCi/VIAL | ||||
| Approval Date: | Mar 9, 1982 | TE: | RLD: | No | |||||
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