Drug Master Files for: tolvaptan

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tolvaptan Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
27052	A	II	4/3/2013	HETERO DRUGS LTD	TOLVAPTAN
27132	A	II	5/22/2013	ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD	TOLVAPTAN
27636	A	II	12/4/2013	APOTEX PHARMACHEM INDIA PVT LTD	TOLVAPTAN
27808	A	II	12/28/2013	MSN LABORATORIES PRIVATE LTD	TOLVAPTAN (AMORPHOUS) [ROUTE CODE TNA]
27833	A	II	1/13/2014	JIANGSU HENGRUI MEDICINE CO LTD	TOLVAPTAN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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