Drug Master Files for: DOLUTEGRAVIR SODIUM

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DOLUTEGRAVIR SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
28721	A	II	10/14/2014	AUROBINDO PHARMA LTD	DOLUTEGRAVIR SODIUM
30011	A	II	11/26/2015	MYLAN LABORATORIES LTD	DOLUTEGRAVIR SODIUM
30055	A	II	3/17/2016	CIPLA LTD	DOLUTEGRAVIR SODIUM
30365	A	II	2/3/2016	SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD	DOLUTEGRAVIR SODIUM
30544	A	II	5/20/2016	HETERO LABS LTD	DOLUTEGRAVIR SODIUM
30933	A	II	12/19/2016	LEK PHARMACEUTICALS DD	DOLUTEGRAVIR SODIUM
30935	A	II	9/28/2016	LAURUS LABS LTD	DOLUTEGRAVIR SODIUM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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