Drug Master Files for: GLAXOSMITHKLINE

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GLAXOSMITHKLINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10729	A	V	2/23/1994	GLAXOSMITHKLINE LLC	PHARMACOLOGY AND TOXICOLOGY INFORMATION REGARDING PROPELLANT HFA-134A (GR106642X)
13207	A	II	4/30/1998	GLAXOSMITHKLINE LLC	AMOXICILLIN TRIHYDRATE
13338	I	II	9/1/1998	GLAXOSMITHKLINE LLC	GRISEOFULVIN
13961	I	II	1/29/1999	GLAXOSMITHKLINE LLC	MUPIROCIN FREE ACID AND MUPIROCIN CALCIUM (NON-STERILE)
14475	I	II	10/13/1999	GLAXOSMITHKLINE	PAROXETINE HYDROCHLORIDE HEMIHYDRATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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