Drug Master Files for: LACTITOL

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LACTITOL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13952	I	II	12/4/1998	CULTOR FOOD SCIENCE INC	LACTITOL MONOHYDRATE
13970	I	II	12/4/1998	CULTOR FOOD SCIENCE INC	LACTITOL, DIRECTLY COMPRESSIBLE FORM,(FINLAC DC)
27765	A	II	11/21/2013	INALCO SRL	LACTITOL MONOHYDRATE
31871	A	II	9/18/2017	PARTICLE DYNAMICS INTERNATIONAL LLC	DESTAB? LACTITOL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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