Drug Master Files for: PARICALCITOL

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PARICALCITOL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16402	A	II	2/3/2003	CATALENT PHARMA SOLUTIONS LLC	ZEMPLAR (PARICALCITOL) 2 & 4 MCG CAPSULES
20865	A	II	9/19/2007	TEVA PHARMACEUTICAL INDUSTRIES LTD	PARICALCITOL USP
21255	A	II	1/16/2008	ALP PHARM BEIJING CO LTD	PARICALCITOL USP (NON-STERILE DRUG SUBSTANCE)
21880	A	II	8/14/2008	FORMOSA LABORATORIES INC	PARICALCITOL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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