Drug Master Files for: telbivudine

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telbivudine Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
24429	I	II	12/8/2010	RANBAXY LABORATORIES LTD	TELBIVUDINE
26493	I	II	9/28/2012	SICHUAN XIELI PHARMACEUTICAL CO LTD	TELBIVUDINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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