Drug Master Files for: FLUOROURACIL
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FLUOROURACIL Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 1138 | I | II | 2/2/1968 | INTERNATL CHEM & NUCLEAR PHARMS INC | 5-FLUOROURACIL |
| 1226 | I | II | 8/21/1968 | PCR INC | 5-FLUOROURACIL |
| 12738 | A | II | 11/11/1997 | AMCOL HEALTH AND BEAUTY SOLUTIONS INC | FLUOROURACIL IN MICROSPONGE? POLYMER (FLUROURACIL IN METHYL METHACRYLATE/DIMETHACRYLATE CROSSPOLYMER) |
| 17832 | I | II | 9/8/2004 | NANTONG GENERAL PHARMACEUTICAL FACTORY | FLUOROURACIL |
| 18478 | A | II | 6/28/2005 | NANTONG JINGHUA PHARMACEUTICAL CO LTD | FLUOROURACIL USP |
| 18975 | I | II | 11/28/2005 | DSM NUTRITIONAL PRODUCTS LTD | 5-FLUOROURACIL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
