Drug Master Files for: amifostine

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amifostine Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17186	A	II	2/26/2004	SUN PHARMACEUTICAL INDUSTRIES LTD	AMIFOSTINE USP
18898	I	II	10/8/2005	AXITEC CO LTD	AMIFOSTINE USP (NON-STERILE BULK DRUG)
21765	A	II	6/26/2008	LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTD	AMIFOSTINE
22873	I	II	5/26/2009	CHANGZHOU AHK TECH INC	AMIFOSTINE
22909	A	II	6/26/2009	ALBEMARLE CORP	AMIFOSTINE
9103	I	II	4/30/1991	SIPSY SNC	AMIFOSTINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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