Drug Master Files for: LACTULOSE

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LACTULOSE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10145	A	II	3/19/1993	CANLAC GROUP ABBOTT LABORATORIES LTD	LACTULOSE CONCENTRATE USP
11262	I	II	12/25/1994	INALCO SPA	LACTULOSE CRYSTALS
11448	I	II	4/11/1995	SOLVAY DUPHAR BV	LACTULOSE CONCENTRATE
12699	I	II	10/14/1997	SOLVAY DUPHAR BV	LACTULOSE CRYSTALLINE
15253	A	II	2/16/2001	FRESENIUS KABI AUSTRIA GMBH	LACTULOSE SOLUTION USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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