Drug Master Files for: ulipristal acetate
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ulipristal acetate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 21527 | A | II | 4/11/2008 | CRYSTAL PHARMA SAU | ULIPRISTAL ACETATE MICRONIZED |
| 25701 | A | II | 1/9/2012 | FORMOSA LABORATORIES INC | ULIPRISTAL ACETATE |
| 26861 | A | II | 2/4/2013 | GEDEON RICHTER PLC | ULIPRISTAL ACETATE MICRONIZED |
| 27945 | A | II | 4/13/2014 | TEVA PHARMACEUTICAL INDUSTRIES LTD | ULIPRISTAL ACETATE |
| 32234 | A | II | 11/17/2017 | NEWCHEM SPA | ULIPRISTAL ACETATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
