Drug Master Files for: colchicine

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colchicine Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10088	A	II	2/10/1993	INDENA SPA	COLCHICINE USP
11771	I	II	12/12/1995	SM ORGANICS PRIVATE LTD	COLCHICINE
17003	I	II	12/1/2003	ALCHEM INTERNATIONAL LTD	COLCHICINE USP
18032	I	II	1/25/2005	ALKALOIDS CORP	COLCHICINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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