Drug Master Files for: nevirapine

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nevirapine Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17782	A	II	10/26/2004	HETERO LABS LTD	NEVIRAPINE
17851	A	II	11/16/2004	AUROBINDO PHARMA LTD	NEVIRAPINE ANHYDROUS USP
17905	A	II	12/17/2004	CIPLA LTD	NEVIRAPINE USP
17915	A	II	12/16/2004	MYLAN LABORATORIES LTD	NEVIRAPINE USP (ANHYDROUS)
18401	A	II	5/22/2005	AUROBINDO PHARMA LTD	NEVIRAPINE HEMIHYDRATE USP
18576	A	II	7/30/2005	AUROBINDO PHARMA LTD	NEVIRAPINE ANHYDROUS USP
19368	I	II	4/14/2006	MYLAN LABORATORIES LTD	NEVIRAPINE HEMIHYDRATE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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