Drug Master Files for: PREDNICARBATE

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PREDNICARBATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16485	I	II	3/25/2003	CHEMAGIS LTD	PREDNICARBATE
17031	A	II	12/19/2003	TEVA PHARMACEUTICAL INDUSTRIES LTD	PREDNICARBATE DRUG SUBSTANCE
20510	A	II	5/7/2007	TARO PHARMACEUTICAL INDUSTRIES LTD	PREDNICARBATE USP MICRONIZED
25504	A	II	6/2/2011	SANOFI AVENTIS DEUTSCHLAND GMBH	PREDNICARBATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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