Drug Master Files for: rifampin
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rifampin Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10027 | I | II | 12/30/1992 | SOLCHEM ITALIANA S P A | RIFAMPIN |
13214 | A | II | 4/30/1998 | LUPIN LTD | RIFAMPIN USP |
13383 | A | II | 9/1/1998 | SANOFI SPA | RIFAMPIN, USP |
13398 | I | II | 9/1/1998 | NOVARTIS PHARMACEUTICALS CORP | RIFAMPIN |
13644 | I | II | 9/1/1998 | SICHUAN LONG MARCH PHARMACEUTICAL CO LTD | RIFAMPIN |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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