Drug Master Files for: NITROFURANTOIN

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NITROFURANTOIN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13266	A	II	10/5/1998	FIS FABBRICA ITALIANA SINTETICI SPA	NITROFURANTOIN MONOHYDRATE
1543	I	II	7/7/1970	ASSIA CHEMICAL LABORATORIES LTD	MANUFACTURE OF NITROFURANTOIN
15504	A	II	7/11/2001	TEVA PHARMACEUTICAL INDUSTRIES LTD	NITROFURANTOIN MACROCRYSTALS USP
16505	A	II	4/22/2003	TEVA PHARMACEUTICAL INDUSTRIES LTD	NITROFURANTOIN MONOHYDRATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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