Drug Master Files for: IMATINIB MESYLATE
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IMATINIB MESYLATE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
19499 | A | II | 6/6/2006 | SUN PHARMACEUTICAL INDUSTRIES LTD | IMATINIB MESYLATE |
20410 | A | II | 4/5/2007 | NATCO PHARMA LTD | IMATINIB MESYLATE (ALPHA 2-FORM) |
21006 | A | II | 11/2/2007 | TEVA PHARMACEUTICAL INDUSTRIES LTD | IMATINIB MESYLATE |
23139 | I | II | 10/1/2009 | MYLAN LABORATORIES LTD | IMATINIB MESYLATE |
23343 | A | II | 11/30/2009 | ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD | IMATINIB MESYLATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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