Drug Master Files for: indium
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indium Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 1097 | I | II | 11/9/1967 | UNITED STATES DEPT ENERGY | TIN-113/INDIUM-113m (D FORMERLY HELD BY UNION CARBIDE CORP) |
| 11937 | I | II | 6/12/1996 | MOUNT SINAI MEDCTR | INDIUM-111 CHLORIDE STERILE SOLUTION |
| 11999 | I | II | 6/12/1996 | MOUNT SINAI MEDCTR | BULK RADIOCHEMICAL INDIUM-111 CHLORIDE |
| 13152 | A | II | 8/25/1998 | ISO TEX DIAGNOSTICS INC | INDIUM-111 |
| 17775 | I | II | 10/21/2004 | THERAGENICS CORP | BULK INDIUM CHLORIDE IN-111 RADIOCHEMICAL |
| 18625 | I | II | 9/3/1993 | NEORX CORP | MURINE MONOCLONAL ANTIBODY (NR-LU-10)/STREPTAVADIN CONJUGATE LABELED W/RHENIUM-186 CONJUGATE (MAG2GABA), BIOTIN-GALACTOSE-HSA, INDIUM-111/YTTRIUM-90-DOTA-BIOTIN |
| 18656 | I | II | 11/4/1998 | NEORX CORP | INDIUM-IN-111 RADIOLABELED HUMANIZED MAB SINGLE CHAIN FV/STREPTAVIDIN FUSION PROTEIN (HUNRLU10 SCFV/SA), BIOTIN-GALACTOSE (SYNTHETIC), IN-111/Y-90-DOTA-BIOTIN |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
