Drug Master Files for: NINTEDANIB ESYLATE

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NINTEDANIB ESYLATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
31526	A	II	3/27/2017	MSN LABORATORIES PRIVATE LTD	NINTEDANIB ESYLATE
32152	A	II	12/28/2017	GLENMARK PHARMACEUTICALS LTD	NINTEDANIB ESYLATE
32408	A	II	1/5/2018	FORMOSA LABORATORIES INC	NINTEDANIB
32504	A	II	3/29/2018	CIPLA LTD	NINTEDANIB ESYLATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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