Drug Master Files for: ADEFOVIR DIPIVOXIL

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ADEFOVIR DIPIVOXIL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20192	I	II	3/27/2007	CIPLA LTD	ADEFOVIR DIPIVOXIL
23844	A	II	6/3/2010	SIGMAPHARM LABORATORIES LLC	AMORPHOUS ADEFOVIR DIPIVOXIL (11.6% COPOVIDONE DISPERSION)
23993	I	II	7/26/2010	SUN PHARMACEUTICAL INDUSTRIES LTD	ADEFOVIR DIPIVOXIL
24151	A	II	8/28/2010	ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD	ADEFOVIR DIPIVOXIL DMC (ADVANCE INTERMEDIATE)
24336	I	II	10/21/2010	ALP PHARM BEIJING CO LTD	ADEFOVIR DIPIVOXIL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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