Drug Master Files for: guaifenesin

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guaifenesin Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10413	A	II	8/13/1993	SYNTHOKEM LABS PRIVATE LTD	GUAIFENESIN USP
10988	I	II	7/19/1994	SIANG TA PHARMACEUTICAL CO LTD	GUAIFENESIN
14234	A	II	6/24/1999	CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD	GUAIFENESIN 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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