Drug Master Files for: FLECAINIDE ACETATE
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FLECAINIDE ACETATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10688 | A | II | 1/24/1994 | MAPRIMED SA | FLECAINIDE ACETATE PROCESS I (CODE 50064) |
| 14749 | A | II | 2/29/2000 | AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA | FLECAINIDE ACETATE |
| 15244 | A | II | 1/15/2001 | POLYCARBON INDUSTRIES INC DBA PCI SYNTHESIS | FLECAINIDE ACETATE USP |
| 19272 | A | II | 3/23/2006 | UNIMARK REMEDIES LTD | FLECAINIDE ACETATE USP |
| 23192 | A | II | 10/14/2009 | UNIMARK REMEDIES LTD | FLECAINIDE ACETATE USP (PROCESS B) |
| 24309 | I | II | 10/13/2010 | MAPRIMED SA | FLECAINIDE ACETATE PROCESS II (CODE 50856) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
