Drug Master Files for: nystatin

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nystatin Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12557	I	II	6/19/1997	SHAOXING PHARMACEUTICAL FACTORY	NYSTATIN
13298	I	II	9/1/1998	ER SQUIBB AND SONS INC	NYSTATIN
13441	I	II	9/1/1998	BRISTOL MYERS SQUIBB CO	NYSTATIN
13523	A	II	9/1/1998	DSM SINOCHEM PHARMACEUTICALS NETHERLANDS BV	NYSTATIN
14056	A	II	4/5/1999	VUAB PHARMA AS	NYSTATIN 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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