Drug Master Files for: DRONEDARONE HYDROCHLORIDE
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DRONEDARONE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18409 | A | II | 6/8/2005 | SANOFI CHIMIE | DRONEDARONE HYDROCHLORIDE |
| 25669 | A | II | 2/16/2012 | UNIMARK REMEDIES LTD | DRONEDARONE HYDROCHLORIDE |
| 26023 | A | II | 4/25/2012 | MYLAN LABORATORIES LTD | DRONEDARONE HYDROCHLORIDE |
| 26085 | A | II | 6/28/2012 | GLENMARK PHARMACEUTICALS LTD | DRONEDARONE HYDROCHLORIDE |
| 26479 | A | II | 5/2/2013 | CHEMWERTH INC | DRONEDARONE HYDROCHLORIDE NON-STERILE BULK DRUG |
| 26593 | A | II | 12/23/2012 | WISDOM PHARMACEUTICAL CO LTD | DRONEDARONE HYDROCHLORIDE |
| 26901 | A | II | 3/26/2013 | ALKEM LABORATORIES LTD | DRONEDARONE HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
