Drug Master Files for: NITROFURANTOIN
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NITROFURANTOIN Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
13266 | A | II | 10/5/1998 | FIS FABBRICA ITALIANA SINTETICI SPA | NITROFURANTOIN MONOHYDRATE |
1543 | I | II | 7/7/1970 | ASSIA CHEMICAL LABORATORIES LTD | MANUFACTURE OF NITROFURANTOIN |
15504 | A | II | 7/11/2001 | TEVA PHARMACEUTICAL INDUSTRIES LTD | NITROFURANTOIN MACROCRYSTALS USP |
16505 | A | II | 4/22/2003 | TEVA PHARMACEUTICAL INDUSTRIES LTD | NITROFURANTOIN MONOHYDRATE USP |
1733 | I | II | 6/8/1971 | GEMA SA | NITROFURANTOIN U.S.P |
1860 | I | II | 1/26/1972 | CAMBREX PROFARMACO MILANO SRL | NITROFURANTOIN ANHYDROUS |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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