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Last Updated: April 26, 2024

Drug Master Files for: Iso Tex

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Iso Tex Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10365	I	II	7/16/1993	ISO TEX DIAGNOSTICS INC	IODINE-125
13152	A	II	8/25/1998	ISO TEX DIAGNOSTICS INC	INDIUM-111
13160	A	II	8/27/1998	ISO TEX DIAGNOSTICS INC	PLATINUM-195M (PT-195M)
13837	A	II	11/12/1998	ISO TEX DIAGNOSTICS INC	PT-195M CIS-PLATIN
13838	A	II	11/12/1998	ISO TEX DIAGNOSTICS INC	PLATINUM-195M
14045	A	II	3/31/1999	ISO TEX DIAGNOSTICS INC	YTTRIUM-90 (Y-90)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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