Drug Master Files for: EPTIFIBATIDE

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EPTIFIBATIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14267	A	II	7/6/1999	ASPEN OSS BV	EPTIFIBATIDE
18565	A	II	8/1/2005	POLYPEPTIDE SA	EPTIFIBATIDE DRUG SUBSTANCE
21913	A	II	8/28/2008	TEVA PHARMACEUTICAL INDUSTRIES LTD	EPTIFIBATIDE
23786	A	II	4/30/2010	ALP PHARM BEIJING CO LTD	EPTIFIBATIDE
24864	A	II	4/18/2011	AMBIOPHARM INC	EPTIFIBATIDE (NON-STERILE, BULK DRUG SUBSTANCE)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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