Drug Master Files for: LEUCOVORIN CALCIUM

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LEUCOVORIN CALCIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10232	I	II	3/6/1993	LABOCHIM SPA	LEUCOVORIN CALCIUM
16718	I	II	7/18/2003	GMT FINE CHEMCALS SA	LEUCOVORIN CALCIUM, USP
25198	A	II	8/10/2011	GMT FINE CHEMICALS SA	LEVOLEUCOVORIN CALCIUM
25334	I	II	8/9/2011	ALP PHARM BEIJING CO LTD	LEUCOVORIN CALCIUM
3715	I	II	2/11/1980	CYANAMID GMBH	LEUCOVORIN CALCIUM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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