Drug Master Files for: Sandoz
✉ Email this page to a colleague
Sandoz Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10521 | I | II | 10/5/1993 | SANDOZ AG | FACILITIES AND PROCEDURES IN NUREMBERG, GERMANY |
10834 | I | II | 3/25/1994 | SANDOZ CANADA INC | FACILITIES AND PROCEDURES IN WHITBY, ONTARIO, CANADA. |
10838 | A | II | 3/29/1994 | SANDOZ GMBH | 7-PACA (7-AMINO-3-PROPENYL-CEPHALOSPORANIC ACID) |
10979 | I | IV | 7/7/1994 | SANDOZ PHARMA LTD | CORN OIL-MONO-DI-TRIGLYCERIDES |
11002 | I | I | 7/22/1994 | SANDOZ LTD | MANUFACTURING FACILITIES, PERSONENEL, AND GENERAL OPERATING PROCEDURES IN CO. CORK, IRELAND. |
11098 | I | II | 9/26/1994 | SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT | CLOZAPINE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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