Drug Master Files for: flucytosine
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flucytosine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15476 | I | II | 6/7/2001 | ACETO CORP | FLUCYTOSINE USP |
| 23503 | A | II | 1/22/2010 | CALYX CHEMICALS AND PHARMACEUTICALS LTD | FLUCYTOSINE |
| 25094 | A | II | 7/14/2011 | NANTONG JINGHUA PHARMACEUTICAL CO LTD | FLUCYTOSINE |
| 28247 | A | II | 6/16/2014 | APICORE US LLC | FLUCYTOSINE, USP |
| 31959 | A | II | 8/30/2017 | MAITHRI LABORATORIES PRIVATE LTD | FLUCYTOSINE USP |
| 32090 | A | II | 11/10/2017 | SOLARA A PHARMA SCIENCES LTD | FLUCYTOSINE USP |
| 9259 | I | II | 7/25/1991 | HOFFMANN LA ROCHE INC | FLUCYTOSINE CAPSULES AND MATCHING PLACEBO |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
