Drug Master Files for: emtricitabine

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emtricitabine Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
19566	A	II	6/30/2006	MYLAN LABORATORIES LTD	EMTRICITABINE
19785	A	II	9/22/2006	CIPLA LTD	EMTRICITABINE
20708	A	II	7/18/2007	AUROBINDO PHARMA LTD	EMTRICITABINE (NON-STERILE) DRUG SUBSTANCE
21612	A	II	5/9/2008	HETERO LABS LTD	EMTRICITABINE
21706	I	II	6/17/2008	RANBAXY LABORATORIES LTD	EMTRICITABINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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