Drug Master Files for: flunisolide
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flunisolide Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11574 | A | II | 7/7/1995 | TEVA PHARMACEUTICAL INDUSTRIES LTD | FLUNISOLIDE ANHYDROUS |
| 11751 | A | III | 8/15/1996 | 3M DRUG DELIVERY SYSTEMS | CONTAINER CLOSURE COMPONENTS FOR HFA134A FLUNISOLIDE METERED DOSE INHALER (MDI) |
| 16935 | I | II | 10/20/2003 | DR REDDYS LABORATORIES LTD | FLUNISOLIDE HEMIHYDRATE |
| 19477 | A | II | 5/31/2006 | FARMABIOS SPA | FLUNISOLIDE ANHYDROUS USP |
| 20375 | A | II | 3/26/2007 | STERLING SPA | FLUNISOLIDE ANHYDROUS |
| 22772 | A | II | 5/13/2009 | TEVA PHARMACEUTICAL INDUSTRIES LTD | FLUNISOLIDE ANHYDROUS (NEW PROCESS) |
| 26148 | A | II | 6/12/2012 | FARMABIOS SPA | FLUNISOLIDE HEMIHYDRATE (MICRONIZED) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
