Drug Master Files for: lacosamide

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lacosamide Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
24599	I	II	2/1/2011	DR REDDYS LABORATORIES LTD	LACOSAMIDE
26136	A	II	6/7/2012	HETERO DRUGS LTD	LACOSAMIDE
26174	A	II	10/9/2012	SUN PHARMACEUTICAL INDUSTRIES LTD	LACOSAMIDE
26250	I	II	10/26/2012	SUN PHARMACEUTICAL INDUSTRIES LTD	LACOSAMIDE
26270	A	II	7/21/2012	MSN PHARMACHEM PRIVATE LTD	LACOSAMIDE [ROUTE CODE - LD]
26313	A	II	8/30/2012	AUROBINDO PHARMA LTD	LACOSAMIDE (NON-STERILE DRUG SUBSTANCE)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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