Drug Master Files for: cefprozil

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cefprozil Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16973	I	II	11/21/2003	SUN PHARMACEUTICAL INDUSTRIES LTD	CEFPROZIL USP (NON-STERILE BULK)
17375	A	II	5/13/2004	ORCHID PHARMA LTD	CEFPROZIL
17453	I	II	6/7/2004	SANDOZ PRIVATE LTD	CEFPROZIL
17731	A	II	9/29/2004	LUPIN LTD	CEFPROZIL USP
17827	A	II	11/16/2004	TEVA PHARMACEUTICAL INDUSTRIES LTD	CEFPROZIL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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