Drug Master Files for: zileuton
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zileuton Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 24334 | A | II | 4/1/2011 | APICORE US LLC | ZILEUTON USP |
| 24827 | A | II | 4/5/2011 | MSN LABORATORIES PRIVATE LTD | ZILEUTON USP [ROUTE CODE ZN] |
| 25805 | A | II | 3/26/2012 | EMCURE PHARMACEUTICALS LTD | ZILEUTON USP |
| 26446 | A | II | 9/26/2012 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | ZILEUTON |
| 26995 | A | II | 3/15/2013 | ERREGIERRE SPA | ZILEUTON USP |
| 27679 | I | II | 10/30/2013 | FARMAK AS | ZILEUTON |
| 31578 | A | II | 7/29/2017 | SOLARA A PHARMA SCIENCES LTD | ZILEUTON USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
