Drug Master Files for: afatinib dimaleate
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afatinib dimaleate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 30927 | A | II | 12/31/2016 | FRESENIUS KABI ONCOLOGY LTD | AFATINIB DIMALEATE |
| 31285 | A | II | 12/31/2016 | MSN LABORATORIES PRIVATE LTD | AFATINIB DIMALEATE (FORM-R) |
| 31302 | A | II | 1/12/2017 | TEVA PHARMACEUTICAL INDUSTRIES LTD | AFATINIB DIMALEATE |
| 31515 | A | II | 5/31/2017 | SUN PHARMACEUTICAL INDUSTRIES LTD | AFATINIB DIMALEATE |
| 31611 | A | II | 4/11/2017 | HETERO LABS LTD | AFATINIB DIMALEATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
