Drug Master Files for: iodine
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iodine Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10365 | I | II | 7/16/1993 | ISO TEX DIAGNOSTICS INC | IODINE-125 |
1119 | I | II | 1/3/1968 | UNITED STATES DEPT ENERGY | IODINE-123 (D FORMERLY HELD BY UNION CARBIDE CORP) |
1137 | I | II | 1/30/1968 | UNITED STATES DEPT ENERGY | IODINE-131 (D FORMERLY HELD BY UNION CARBIDE CORP) |
11857 | I | II | 2/9/1996 | WOODWARD IODINE CORP | IODINE (USP IODINE) |
14303 | A | II | 7/14/1999 | NTP RADIOISOTOPES SOC LTD | FISSION IODINE-131 |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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