Drug Master Files for: DACLATASVIR DIHYDROCHLORIDE

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DACLATASVIR DIHYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
30737	A	II	8/11/2016	CIPLA LTD	DACLATASVIR DIHYDROCHLORIDE
30975	A	II	10/7/2016	HETERO LABS LTD	DACLATASVIR DIHYDROCHLORIDE
32471	A	II	3/29/2018	GLENMARK PHARMACEUTICALS LTD	DACLATASVIR DIHYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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