Drug Master Files for: CEFOTAXIME SODIUM

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CEFOTAXIME SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12632	I	II	8/27/1997	HAMNMI FINE CHEMICAL CO LTD	CEFOTAXIME ACID
13219	A	II	4/30/1998	LUPIN LTD	STERILE CEFOTAXIME SODIUM USP
14367	A	II	8/25/1999	ACS DOBFAR SPA	CEFOTAXIME SODIUM STERILE
15272	A	II	1/30/2001	ACS DOBFAR SPA	CEFOTAXIME ACID
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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