Drug Master Files for: ELVITEGRAVIR

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ELVITEGRAVIR Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
25187	A	II	10/21/2011	GILEAD SCIENCES INC	ELVITEGRAVIR
27727	A	II	12/27/2013	MYLAN LABORATORIES LTD	ELVITEGRAVIR
29558	A	II	8/28/2015	MYLAN LABORATORIES LTD	ELVITEGRAVIR (PROCESS-II)
30772	A	II	8/30/2016	MSN LIFE SCIENCES PRIVATE LTD	ELVITEGRAVIR (FORM-II)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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