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Last Updated: April 18, 2024

Drug Master Files for: Smithkline Beecham

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Smithkline Beecham Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10266	I	II	6/3/1993	SMITHKLINE BEECHAM PHARMACEUTICALS	BRL 47539 (2-ACETOXYMETHYL-4-IODOBUT-1-YL-ACETATE)
10267	I	II	6/3/1993	SMITHKLINE BEECHAM PHARMACEUTICALS	BRL 47539 (2-ACETOXYMETHYL-4-IODOBUT-1-YL-ACETATE)
11041	I	II	6/24/1994	SMITHKLINE BEECHAM PHARMACEUTICALS CO	PENICILLIN G POTASSIUM, NON-STERILE, TECHNICAL GRADE
11400	I	II	3/24/1995	SMITHKLINE BEECHAM PHARMACEUTICALS	MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CUERNAVACA, MEXICO.
11805	I	II	1/11/1996	SMITHKLINE BEECHAM PHARMACEUTICALS	CIMETIDINE
12933	I	II	3/31/1998	SMITHKLINE BEECHAM	6-AMINOPENICILLANIC ACID [6-APA]
13201	I	II	4/30/1998	SMITHKLINE BEECHAM	AMOXICILLIN TRIHYDRATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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