Drug Master Files for: PROPAFENONE HYDROCHLORIDE
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PROPAFENONE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10641 | A | II | 12/16/1993 | PHARMAZELL GMBH | PROPAFENONE HYDROCHLORIDE |
| 11426 | A | II | 4/3/1995 | PROCOS SPA | PROPAFENONE HYDROCHLORIDE |
| 11568 | A | II | 6/29/1995 | FERMION OY | PROPAFENONE HCL |
| 12691 | I | II | 10/9/1997 | SIEGFRIED CHEMIE AG LTD | PROPAFENONE HYDROCHLORIDE |
| 13010 | A | II | 6/1/1998 | ERREGIERRE SPA | PROPAFENONE HYDROCHLORIDE USP-EP |
| 14985 | A | II | 8/29/2000 | CAMBREX PROFARMACO MILANO SRL | PROPAFENONE HYDROCHLORIDE |
| 20418 | A | II | 3/15/2007 | MYLAN LABORATORIES LTD | PROPAFENONE HYDROCHLORIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
