Drug Master Files for: Novo Nordisk
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Novo Nordisk Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10480 | I | II | 9/2/1993 | NOVO NORDISK AS | FACILITIES IN BAGSVAERD, KALUNDBORG, COPENHAGEN, SOEBERG, HILLEROED AND VAERLOESE, DENMARK |
10603 | I | II | 11/29/1993 | NOVO NORDISK PHARMACEUTICALS INC | FACILITIES AND PROCEDURES IN DENMARK |
14025 | I | V | 3/12/1999 | NOVO NORDISK PHARMACEUTICALS INC | STERILIZATION PROCESS VALIDATION INFORMATION AT NOVO NORDISK PHARMACEUTICALS IN CLAYTON NC |
1536 | I | II | 6/9/1970 | NOVO NORDISK AS | BOVINE PROTEOLYTIC ENZYME MIXTURE (BOVINE PEM) BVF 8001 70) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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