Drug Master Files for: LAMIVUDINE

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LAMIVUDINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17535	A	II	7/19/2004	CIPLA LTD	LAMIVUDINE USP
17750	A	II	10/8/2004	MYLAN LABORATORIES LTD	LAMIVUDINE USP
17900	A	II	12/3/2004	AUROBINDO PHARMA LTD	LAMIVUDINE USP
18252	A	II	4/7/2005	HETERO LABS LTD	LAMIVUDINE USP (PROCESS I)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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