Drug Master Files for: Novo Nordisk Inc

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Novo Nordisk Inc Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
21494	A	V	5/1/2008	NOVO NORDISK INC	STERILIZATION VALIDATION INFORMATION IN BAGSVAERD, DENMARK
24470	A	V	3/6/2013	NOVO NORDISK INC	STERILIZATION VALIDATION INFORMATION
32485	A	V	5/1/2018	NOVO NORDISK INC	STERILIZATION VALIDATION INFORMATION
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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