Drug Master Files for: ranolazine
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ranolazine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 21866 | A | II | 8/7/2008 | AARTI INDUSTRIES LTD | RANOLAZINE |
| 21966 | A | II | 12/3/2008 | CIPLA LTD | RANOLAZINE |
| 22350 | A | II | 12/22/2008 | MSN PHARMACHEM PRIVATE LTD | RANOLAZINE [ROUTE CODE - RA] |
| 22811 | A | II | 6/15/2009 | COSMA SPA | RANOLAZINE |
| 23245 | A | II | 12/24/2009 | LUPIN LTD | RANOLAZINE |
| 23401 | A | II | 12/23/2009 | PAR A TECHNOLOGIES PRIVATE LTD | RANOLAZINE (NON-STERILE BULK DRUG SUBSTANCE) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
