Drug Master Files for: FOSCARNET SODIUM
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FOSCARNET SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11385 | I | II | 3/15/1995 | JIANGSU TIANQING PHARMACEUTICAL FACTORY | FOSCARNET SODIUM |
| 19085 | A | II | 1/4/2006 | TRIFARMA SPA | FOSCARNET SODIUM |
| 28996 | A | II | 1/30/2015 | CHEMWERTH INC | FOSCARNET SODIUM USP |
| 29056 | A | II | 2/5/2015 | LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTD | FOSCARNET SODIUM, NON STERILE, BULK DRUG SUBSTANCE |
| 29814 | A | II | 9/28/2015 | GLAND PHARMA LTD | FOSCARNET SODIUM USP |
| 32652 | A | II | 3/30/2018 | EMCURE PHARMACEUTICALS LTD | FOSCARNET SODIUM USP |
| 6036 | I | II | 10/2/1985 | ASTRA CLINICAL RESEARCH ASSOC INC | FOSCARNET SODIUM INTRAVENOUS SOLUTION |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
