Drug Master Files for: dalteparin sodium

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dalteparin sodium Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
19038	I	II	12/15/2005	RELIABLE BIOPHARMACEUTICAL CORP	DALTEPARIN SODIUM
19658	I	II	8/4/2006	OPOCRIN SPA	DALTEPARIN SODIUM BULK
20541	A	II	3/27/2007	CHANGZHOU QIANHONG BIO PHARMA CO LTD	DALTEPARIN SODIUM
20905	I	II	9/25/2007	DONGYING TIANDONG PHARMACEUTICAL CO LTD	DALTEPARIN SODIUM 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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