Drug Master Files for: xenon xe-133
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xenon xe-133 Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
1625 | I | II | 12/7/1970 | GENERAL ELECTRIC CO | FISSION PRODUCT XENON-133 |
2371 | I | II | 12/12/1974 | STUDSVIK ISOTOPSERVICE AB | RADIOA XENON-133 GAS |
2802 | I | II | 12/10/1976 | DIAGNOSTIC ISOTOPES INC | XENON, XE-127 |
2823 | I | II | 12/23/1976 | UNION CARBIDE CORP | XENON-133 PL AND XENON-133 P2 |
30409 | A | II | 6/2/2016 | PRAXAIR RARE GASES AND HELIUM | XENON GAS FOR INHALATION, FOR CLINICAL TRIALS |
>DMF No. | >Status | >Type | >Submission Date | >Holder | >Subject |
Drug Master File Glossary
STATUS OF DMFS
- A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
- I = Inactive
- N = Not an assigned number
- P = DMF Pending Filing Review
TYPES OF DMFs
- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III Packaging Material
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V FDA Accepted Reference Information