Drug Master Files for: ACETYLCYSTEINE

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ACETYLCYSTEINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14304	A	II	7/21/1999	MOEHS IBERICA SL	ACETYLCYSTEINE USP
21789	A	II	7/10/2008	NIPPON RIKA CO LTD	ACETYLCYSTEINE DRUG SUBSTANCE
5091	A	II	7/4/1983	FIS FABBRICA ITALIANA SINTETICI SPA	ACETYLCYSTEINE, 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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