Drug Master Files for: FLUOCINONIDE
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FLUOCINONIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14151 | A | II | 5/14/1999 | TARO PHARMACEUTICAL INDUSTRIES LTD | FLUOCINONIDE USP MICRONIZED |
21261 | A | II | 1/23/2008 | TEVA PHARMACEUTICAL INDUSTRIES LTD | FLUOCINONIDE (NEW PROCESS) |
21430 | A | II | 3/13/2008 | FARMABIOS SPA | FLUOCINONIDE, MICRONIZED BP/USP |
3112 | I | II | 1/3/1978 | ANTIBIOTICOS SPA | FLUOCINONIDE (BULK, NON STERILE, NON-MICRONIZED & MICRONIZED) |
4591 | A | II | 7/9/1982 | TEVA PHARMACEUTICAL INDUSTRIES LTD | FLUOCINONIDE |
7384 | I | II | 2/19/1988 | CESQUISA SA | FLUOCINONIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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