Drug Master Files for: MIFEPRISTONE
✉ Email this page to a colleague
MIFEPRISTONE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20504 | I | II | 5/1/2007 | PCAS | MIFEPRISTONE |
| 20949 | I | II | 10/17/2007 | CRYSTAL PHARMA SAU | MIFEPRISTONE, MICRONIZED |
| 21944 | I | II | 9/8/2008 | ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO LTD | MIFEPRISTONE |
| 24628 | A | II | 1/30/2011 | QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD | MIFEPRISTONE |
| 27474 | A | II | 9/13/2013 | FORMOSA LABORATORIES INC | MIFEPRISTONE |
| 31873 | A | II | 7/20/2017 | ZHEJIANG XIANJU PHARMACEUTICAL CO LTD | MIFEPRISTONE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
