Drug Master Files for: RIFAMYCIN SODIUM
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RIFAMYCIN SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11291 | A | II | 1/9/1995 | LUPIN LTD | RIFAMYCIN-S (BULK SUBSTANCE) |
| 11750 | I | II | 11/16/1995 | CKD BIO CORP | RIFAMYCIN-S |
| 11796 | I | II | 1/22/1996 | DIASPA SPA | RIFAMYCIN S BULK |
| 22325 | A | II | 12/9/2008 | LUPIN LTD | RIFAMYCIN O |
| 22907 | A | II | 6/24/2009 | OLON SPA | RIFAMYCIN SV SODUM SALT |
| 23616 | A | II | 3/8/2010 | CKD BIO CORP | RIFAMYCIN SODIUM NON-STERILE BULK |
| 25287 | I | II | 9/9/2011 | SANOFI AVENTIS SPA | RIFAMYCIN SODIUM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
