Drug Master Files for: WARFARIN POTASSIUM
✉ Email this page to a colleague
WARFARIN POTASSIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10530 | I | II | 8/14/1993 | MEDEA RESEARCH LABORATORIES INC | WARFARIN SODIUM |
| 11387 | A | II | 3/15/1995 | APOTEX PHARMACHEM INC | WARFARIN SODIUM CLATHRATE USP |
| 12117 | I | II | 8/27/1996 | NAPP TECHNOLOGIES INC | WARFARIN SODIUM CLATHRATE |
| 12269 | A | II | 12/16/1996 | TEVA PHARMACEUTICAL INDUSTRIES LTD | WARFARIN SODIUM CLATHRATE |
| 12704 | I | II | 10/21/1997 | SHANGHAI SHEN XING PHARMACEUTICAL FACTORY | WARFARIN SODIUM, USP |
| 12746 | A | II | 11/18/1997 | TARO PHARMACEUTICAL INDUSTRIES LTD | WARFARIN SODIUM CLATHRATE USP |
| 12977 | A | II | 5/2/1998 | CADILA HEALTHCARE LTD | WARFARIN SODIUM USP (CRYSTALLINE CLATHRATE) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
