Drug Master Files for: alvimopan

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alvimopan Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
24035	I	II	7/26/2010	ALP PHARM BEIJING CO LTD	ALVIMOPAN DIHYDRATE
25908	I	II	4/2/2012	ALP PHARM BEIJING CO LTD	ALVIMOPAN DIHYDRATE
30553	A	II	5/24/2016	TEVA PHARMACEUTICAL INDUSTRIES LTD	ALVIMOPAN DIHYDRATE
30563	A	II	5/31/2016	MSN LIFE SCIENCES PRIVATE LTD	ALVIMOPAN DIHYDRATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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