Drug Master Files for: CEFTRIAXONE SODIUM

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CEFTRIAXONE SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13656	I	II	9/1/1998	ROCHE PHARMACEUTICALS DIV HOFFMANN LAROCHE INC	CEFTRIAXONE SODIUM
15931	A	II	3/26/2002	LUPIN LTD	CEFTRIAXONE SODIUM USP (STERILE )
16467	A	II	3/12/2003	SANDOZ GMBH	CEFTRIAXONE SODIUM (STERILE)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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