Drug Master Files for: GENTAMICIN SULFATE

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GENTAMICIN SULFATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12048	A	II	6/30/1996	FUJIAN FUKANG PHARMACEUTICAL CO LTD	GENTAMICIN SULFATE
12177	I	I	10/17/1996	FUZHOU ANTIBIOTIC GENERAL FACTORY	MANUFACTURING FACILITIES FOR GENTAMICIN SULFATE IN FUZHOU, P.R. CHINA
13437	I	II	9/1/1998	SCHERING PHARMACEUTICAL CORP	GENTAMICIN SULFATE
13620	I	II	9/1/1998	GIST-BROCADES NV PHARMACEUTICALS	GENTAMICIN SULFATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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