Drug Master Files for: Fresenius Kabi Oncol
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Fresenius Kabi Oncol Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14395 | I | II | 9/8/1999 | FRESENIUS KABI ONCOLOGY LTD | METAXALONE |
17966 | A | II | 12/30/2004 | FRESENIUS KABI ONCOLOGY LTD | PACLITAXEL SEMISYNTHETIC |
18532 | I | II | 7/20/2005 | FRESENIUS KABI ONCOLOGY LTD | DISODIUM PAMIDRONATE |
18818 | A | II | 9/23/2005 | FRESENIUS KABI ONCOLOGY LTD | IRINOTECAN HYDROCHLORIDE TRIHYDRATE |
19610 | A | II | 7/17/2006 | FRESENIUS KABI ONCOLOGY LTD | OXALIPLATIN |
20099 | A | II | 12/28/2006 | FRESENIUS KABI ONCOLOGY LTD | BICALUTAMIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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