Drug Master Files for: Krka Dd Novo Mesto

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Krka Dd Novo Mesto Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12809	I	II	12/29/1997	KRKA DD NOVO MESTO	ENALAPRIL MALEATE
13507	I	II	9/1/1998	KRKA DD NOVO MESTO	OXYTETRACYCLINE
15005	I	II	8/21/2000	KRKA DD NOVO MESTO	ENALAPRILA USP
22321	I	II	12/17/2008	KRKA DD NOVO MESTO	LANSOPRAZOLE A SUBSTANCE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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