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Last Updated: August 7, 2020

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Drug Master Files for: INDIUM IN-111 PENTETATE DISODIUM

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INDIUM IN-111 PENTETATE DISODIUM 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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Serving leading biopharmaceutical companies globally:

Medtronic
Baxter
Mallinckrodt
Merck
AstraZeneca
Moodys

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