Drug Master Files for: CEFIXIME

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CEFIXIME Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13687	I	II	9/1/1998	LEDERLE LABORATORIES	CEFIXIME
15996	A	II	5/20/2002	LUPIN LTD	CEFIXIME USP
16313	I	II	12/17/2002	SANDOZ PRIVATE LTD	CEFIXIME
17655	I	II	9/7/2004	ORCHID CHEMICALS AND PHARMACEUTICALS LTD	CEFIXIME, USP
19307	A	II	3/28/2006	NECTAR LIFESCIENCES LTD	CEFIXIME USP
19960	A	II	11/14/2006	ORCHID PHARMA LTD	CEFIXIME (PROCESS 2)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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