Drug Master Files for: EPROSARTAN MESYLATE
EPROSARTAN MESYLATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15475 | I | II | 5/29/2001 | LONZA LTD | EPROSARTAN |
| 16703 | I | II | 7/14/2003 | DISHMAN PHARMACEUTICALS AND CHEMICALS LTD | EPROSARTAN MESYLATE |
| 16790 | I | II | 8/22/2003 | LONZA LTD | EPROSARTAN MESYLATE (ROUTE F) |
| 18079 | I | II | 2/9/2005 | LONZA AG | EPROSARTAN MESYLATE (ROUTE F1) |
| 18155 | A | II | 3/7/2005 | DISHMAN CARBOGEN AMCIS LTD | EPROSARTAN MESYLATE |
| 22863 | A | II | 8/31/2009 | JUBILANT GENERICS LTD | EPROSARTAN MESYLATE |
| 23274 | A | II | 11/17/2009 | HETERO DRUGS LTD | EPROSARTAN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
