Drug Master Files for: TENOFOVIR ALAFENAMIDE FUMARATE

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TENOFOVIR ALAFENAMIDE FUMARATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20003	A	II	11/29/2006	CIPLA LTD	TENOFOVIR DISOPROXIL FUMARATE
20108	A	II	1/3/2007	MYLAN LABORATORIES LTD	TENOFOVIR DISOPROXIL FUMARATE
21096	A	II	11/23/2007	AUROBINDO PHARMA LTD	Tenofovir Disoproxil Fumarate (Non-Sterile Drug Substance)
21098	I	II	12/3/2007	SUN PHARMACEUTICAL INDUSTRIES LTD	TENOFOVIR DISOPROXIL FUMARATE DRUG SUBSTANCE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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