Drug Master Files for: ERGOCALCIFEROL

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ERGOCALCIFEROL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11142	A	II	10/18/1994	SYNTHESIA AS	ERGOCALCIFEROL USP
15533	A	II	7/13/2001	CATALENT PHARMA SOLUTIONS LLC	DRISDOL SOFTGELS (ERGOCALCIFEROL, 50, 000 IU)
21839	I	II	5/30/2008	SYNTHESIA AS	ERGOCALCIFEROL
23155	I	II	9/18/2009	ALP PHARM BEIJING CO LTD	ERGOCALCIFEROL 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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