Drug Master Files for: ENOXAPARIN SODIUM

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ENOXAPARIN SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16748	I	II	8/8/2003	OPOCRIN SPA	ENOXAPARIN SODIUM
18452	A	II	5/28/2005	DONGYING TIANDONG PHARMACEUTICAL CO LTD	ENOXAPARIN SODIUM (NON-STERILE BULK FORM)
21798	A	II	7/8/2008	CELSUS LABORATORIES INC	ENOXAPARIN SODIUM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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