Drug Master Files for: THIOTEPA

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THIOTEPA Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13911	A	II	12/24/1998	HERAEUS DEUTSCHLAND GMBH AND CO KG	THIOTEPA USP
14170	A	II	6/1/1999	IDT AUSTRALIA LTD	THIOTEPA USP
14316	I	II	7/29/1999	JIANGSU HENGRUI MEDICINE CO LTD	THIOTEPA USP NON STERILE BULK DRUG
14512	I	II	10/26/1999	TEVA PHARMACEUTICAL INDUSTRIES LTD	THIOTEPA
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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