Drug Master Files for: RISEDRONATE SODIUM
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RISEDRONATE SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16604 | A | II | 5/22/2003 | TEVA PHARMACEUTICAL INDUSTRIES LTD | RISEDRONATE SODIUM |
| 18807 | I | II | 9/25/2005 | DIVIS LABORATORIES LTD | RISEDRONATE SODIUM |
| 19968 | A | II | 11/3/2006 | JUBILANT GENERICS LTD | RISEDRONATE SODIUM HEMIPENTAHYDRATE-USP |
| 20162 | A | II | 3/16/2007 | CIPLA LTD | RISEDRONATE SODIUM HEMI PENTAHYDRATE USP |
| 20384 | A | II | 3/26/2007 | ZAKLADY FARMACEUTYCZNE POLPHARMA SA | SODIUM RISEDRONATE HEMI-PENTAHYDRATE |
| 20398 | A | II | 4/2/2007 | MYLAN LABORATORIES LTD | RISEDRONATE SODIUM USP (HEMI-PENTAHYDRATE) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
