Drug Master Files for: FLUOXYMESTERONE
✉ Email this page to a colleague
FLUOXYMESTERONE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
27250 | A | II | 6/21/2013 | CEDARBURG PHARMACEUTICALS INC | FLUOXYMESTERONE A DRUG SUBSTANCE |
3494 | I | II | 4/9/1979 | BLASCHIM SPA | FLUOXYMESTERONE |
4607 | I | II | 7/23/1982 | PFIZER INC | FLUOXYMESTERONE USP |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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