Drug Master Files for: nesiritide

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nesiritide Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
26676	A	II	12/4/2012	BCN PEPTIDES SA	NESIRITIDE
27265	A	II	6/25/2013	HYBIO PHARMACEUTICAL CO LTD	NESIRITIDE CITRATE, NON-STERILE BULK DRUG SUBSTANCE
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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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