Drug Master Files for: FULVESTRANT
✉ Email this page to a colleague
FULVESTRANT Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 22174 | I | II | 11/12/2008 | TEVA PHARMACEUTICAL INDUSTRIES LTD | FULVESTRANT |
| 22611 | A | II | 3/13/2009 | SCINOPHARM TAIWAN LTD | FULVESTRANT USP |
| 26835 | A | II | 3/15/2013 | TEVA PHARMACEUTICAL INDUSTRIES LTD | FULVESTRANT |
| 26855 | A | II | 1/30/2013 | STERLING SPA | FULVESTRANT |
| 26893 | I | II | 3/14/2014 | CHEM WERTH INC | FULVESTRANT |
| 29104 | A | II | 3/9/2015 | INDUSTRIALE CHIMICA SRL | FULVESTRANT USP |
| 29446 | A | II | 6/28/2015 | PERRIGO API LTD | FULVESTRANT |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
