Drug Master Files for: ENTECAVIR

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ENTECAVIR Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
23663	A	II	5/21/2010	CIPLA LTD	ENTECAVIR MONOHYDRATE USP
24305	I	II	10/19/2010	APOTEX PHARMACHEM INDIA PVT LTD	ENTECAVIR USP
24601	A	II	1/28/2011	CHONGQING CARELIFE PHARMACEUTICAL CO LTD	ENTECAVIR HYDRATE USP, NON-STERILE BULK DRUG SUBSTANCE
25200	A	II	8/5/2011	ZHEJIANG AUSUN PHARMACEUTICAL CO LTD	ENTECAVIR MONOHYDRATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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