Drug Master Files for: nintedanib esylate
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nintedanib esylate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 31526 | A | II | 3/27/2017 | MSN LABORATORIES PRIVATE LTD | NINTEDANIB ESYLATE |
| 32152 | A | II | 12/28/2017 | GLENMARK PHARMACEUTICALS LTD | NINTEDANIB ESYLATE |
| 32408 | A | II | 1/5/2018 | FORMOSA LABORATORIES INC | NINTEDANIB |
| 32504 | A | II | 3/29/2018 | CIPLA LTD | NINTEDANIB ESYLATE |
| 32511 | A | II | 3/29/2018 | JOHNSON MATTHEY INC | NINTEDANIB ESYLATE |
| 32529 | A | II | 2/22/2018 | OLON SPA | NINTEDANIB ESYLATE HEMIHYDRATE |
| 32643 | A | II | 4/2/2018 | FORMOSA LABORATORIES INC | NINTEDANIB ESYLATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
