Drug Master Files for: ALENDRONATE SODIUM
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ALENDRONATE SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14334 | A | II | 8/6/1999 | CIPLA LTD | ALENDRONATE SODIUM USP |
| 14983 | I | II | 8/2/2000 | ALCHYMARS SPA | ALENDRONATE SODIUM |
| 15409 | A | II | 4/30/2001 | APOTEX PHARMACHEM INC | ALENDRONATE SODIUM TRIHYDRATE USP |
| 15858 | I | II | 2/12/2002 | CHEMI SPA | SODIUM ALENDRONATE |
| 16129 | A | II | 9/10/2002 | SIGNA SA DE CV | ALENDRONATE SODIUM TRIHYDRATE USP |
| 16367 | I | II | 1/17/2003 | MEDICHEM SA | ALENDRONATE SODIUM |
| 16962 | A | II | 11/17/2003 | ZAKLADY FARMACEUTYCZNE POLPHARMA SA | SODIUM ALENDRONATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
