Drug Master Files for: busulfan
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busulfan Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 21126 | A | II | 12/12/2007 | CHEMPACIFIC CORP | BUSULFAN DRUG SUBSTANCE |
| 23924 | A | II | 8/5/2010 | APICORE US LLC | BUSULFAN USP |
| 24385 | A | II | 11/30/2010 | FRESENIUS KABI ONCOLOGY LTD | BUSULFAN |
| 25393 | I | II | 10/18/2011 | EUTICALS SPA | BUSULFAN |
| 25433 | A | II | 12/29/2011 | EMCURE PHARMACEUTICALS LTD | BUSULFAN USP |
| 25491 | A | II | 12/7/2011 | SHILPA MEDICARE LTD | BUSULFAN USP |
| 25667 | A | II | 2/2/2012 | CHEMWERTH INC | BUSULFAN USP NON-STERILE BULK DRUG |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
