Drug Master Files for: EFAVIRENZ

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EFAVIRENZ Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17802	A	II	10/23/2004	AUROBINDO PHARMA LTD	EFAVIRENZ USP
18230	A	II	3/30/2005	MYLAN LABORATORIES LTD	EFAVIRENZ USP
19932	A	II	10/30/2006	AUROBINDO PHARMA LTD	EFAVIRENZ USP (NON-STERILE DRUG SUBSTANCE)
20015	A	II	12/5/2006	HETERO LABS LTD	EFAVIRENZ (PROCESS I)
20196	I	II	1/16/2007	EMCURE PHARMACEUTICALS LTD	EFAVIRENZ USP
20560	I	II	5/25/2007	RANBAXY LABORATORIES LTD	EFAVIRENZ
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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