Drug Master Files for: lenalidomide
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lenalidomide Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 23410 | A | II | 12/29/2009 | MYLAN LABORATORIES LTD | LENALIDOMIDE |
| 24264 | A | II | 12/2/2010 | APICORE US LLC | LENALIDOMIDE |
| 25872 | I | II | 3/30/2012 | DR REDDYS LABORATORIES LTD | LENALIDOMIDE |
| 27116 | A | II | 6/4/2013 | FIS FABBRICA ITALIANA SINTETICI SPA | LENALIDOMIDE |
| 27905 | A | II | 2/3/2014 | RELIANCE LIFE SCIENCES PVT LTD | LENALIDOMIDE |
| 29628 | A | II | 9/16/2016 | CIPLA LTD | LENALIDOMIDE |
| 29690 | A | II | 9/30/2015 | DR REDDYS LABORATORIES LTD | LENALIDOMIDE DIMETHYLFORMAMIDE SOLVATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
