Drug Master Files for: FLUDARABINE PHOSPHATE
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FLUDARABINE PHOSPHATE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14924 | I | II | 6/15/2000 | BAYER SCHERING PHARMA AG | FLUDARABINE PHOSPHATE |
15542 | I | II | 7/25/2001 | ASH STEVENS INC | FLUDARABINE PHOSPHATE (ASP) |
15742 | A | II | 11/12/2001 | TEVA PHARMACEUTICAL INDUSTRIES LTD | FLUDARABINE PHOSPHATE |
16807 | A | II | 8/27/2003 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | FLUDARABINE PHOSPHATE USP |
17136 | A | II | 1/30/2004 | RELIABLE BIOPHARMACEUTICAL LLC | FLUDARABINE PHOSPHATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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