Drug Master Files for: dofetilide
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dofetilide Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 27816 | A | II | 2/25/2014 | JOHNSON MATTHEY PHARMA SERVICES | 4245.C (MILLED) [DOFETILIDE] |
| 28301 | A | II | 6/5/2014 | SIGMAPHARM LABORATORIES LLC | AMORPHOUS DOFETILIDE |
| 29722 | A | II | 10/7/2015 | APICORE US LLC | DOFETILIDE USP, POLYMORPH P162B |
| 30042 | A | II | 12/17/2015 | INDUSTRIALE CHIMICA SRL | DOFETILIDE USP |
| 30508 | A | II | 6/29/2016 | BIDDLE SAWYER PHARMA LLC | DOFETILIDE USP |
| 30560 | A | II | 6/1/2016 | AUROBINDO PHARMA LTD | DOFETILIDE USP |
| 30718 | A | II | 8/10/2017 | CHEMWERTH INC | DOFETILIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
