Drug Master Files for: URSODIOL

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URSODIOL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16803	A	II	9/3/2003	PRODOTTI CHIMICI E ALIMENTARI SPA	URSODIOL
17717	I	II	10/19/2004	AXCAN PHARMA INC	URSODIOL SUSPENSION, 250 MG/ML
21434	I	II	3/17/2008	DAEWOONG BIO INC	URSODIOL USP (URSODEOXYCHOLIC ACID)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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