Drug Master Files for: Novo
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Novo Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10401 | I | II | 8/3/1993 | SINTENOVO SA DE CV | FACILITIES, PERSONNEL AND OPERATING PROCEDURES AT THE NAUCALPAN (MEXICO) PLANT |
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 |
10604 | I | II | 12/13/1993 | NOVOCOL PHARMACEUTICAL CANADA INC | FACILITY AND PROCEDURES IN CAMBRIDGE, ONTARIO |
10885 | I | II | 4/25/1994 | NOVOPHARM LTD | RANITIDINE HYDROCHLORIDE USP |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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