Drug Master Files for: cyclosporine
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cyclosporine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10281 | I | II | 6/8/1993 | NORTH CHINA PHARMACEUTICAL CORP | CYCLOSPORINE, USP (BULK, NON-STERILE) |
| 11618 | I | II | 8/7/1995 | SANDOZ PHARMA LTD | CYCLOSPORINE MANFACTURED IN BASLE, SWITZERLAND. |
| 11971 | I | II | 5/13/1996 | GALENA AS | CYCLOSPORINE |
| 12214 | A | II | 10/25/1996 | CKD BIO CORP | CYCLOSPORINE, NON-STERILE BULK, USP |
| 12932 | A | II | 4/2/1998 | TEVA PHARMACEUTICAL INDUSTRIES LTD | CYCLOSPORINE |
| 12949 | A | II | 4/13/1998 | EUTICALS SPA | CYCLOSPORINE |
| 13789 | A | II | 9/1/1998 | CHEMWERTH INC | CYCLOSPORINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
