Drug Master Files for: ARSENIC TRIOXIDE

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ARSENIC TRIOXIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20033	A	II	12/13/2006	HERAEUS DEUTSCHLAND GMBH AND CO KG	ARSENIC TRIOXIDE USP
21092	I	II	12/3/2007	TTY BIOPHARM CO LTD	Arsenic Trioxide
26075	A	II	5/18/2012	CHEMWERTH INC	ARSENIC TRIOXIDE, NON-STERILE, BULK DRUG SUBSTANCE
27382	I	II	9/23/2013	CADILA HEALTHCARE LTD	ARSENIC TRIOXIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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