Drug Master Files for: oxaliplatin
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oxaliplatin Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10039 | I | II | 1/15/1993 | TANAKA KIKINZOKU KOGYO | MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF OXALIPLATIN IN KANAGAWA, JAPAN. |
| 10040 | A | II | 1/15/1993 | TANAKA KIKINZOKU KOGYO | OXALIPLATIN |
| 16952 | A | II | 11/11/2003 | JOHNSON MATTHEY INC | OXALIPLATIN |
| 19559 | A | II | 6/28/2006 | TEVA PHARMACEUTICAL INDUSTRIES LTD | OXALIPLATIN |
| 19594 | A | II | 7/11/2006 | PLIVA-LACHEMA AS | OXALIPLATIN |
| 19610 | A | II | 7/17/2006 | FRESENIUS KABI ONCOLOGY LTD | OXALIPLATIN |
| 19633 | A | II | 7/28/2006 | HERAEUS DEUTSCHLAND GMBH AND CO KG | OXALIPLATIN |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
