Drug Master Files for: RIBAVIRIN
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RIBAVIRIN Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
12156 | A | II | 9/30/1996 | SIEGFRIED EVIONNAZ SA | RIBAVIRIN |
12766 | I | II | 11/27/1997 | YAMASA CORP | RIBAVIRIN |
15503 | A | II | 6/21/2001 | STAR LAKE BIOSCIENCE CO INC | RIBAVIRIN, USP |
15611 | A | II | 8/31/2001 | YUHAN CHEMICAL INC | RIBAVIRIN USP, 1H-1,2,4-TRIAZOLE-3-CARBOXAMIDE, 1-BETA-D-RIBOFURANOSYL |
15655 | I | II | 6/22/2001 | XINXIANG PHARMACEUTICAL CO LTD | RIBAVIRIN NON-STERILE BULK FORM |
15700 | A | II | 10/30/2001 | PRIME EUROPEAN THERAPEUTICALS SPA (EUTICALS SPA) | RIBAVIRIN USP-EP |
15756 | A | II | 10/1/2001 | BIDACHEM SPA | RIBAVIRIN |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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