Drug Master Files for: ABIRATERONE ACETATE
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ABIRATERONE ACETATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 26725 | A | II | 11/28/2012 | STERLING SPA | ABIRATERONE ACETATE |
| 26779 | A | II | 12/24/2012 | CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE CO LTD | ABIRATERONE ACETATE (NON-STERILE BULK DRUG SUBSTANCE) |
| 26894 | A | II | 7/30/2014 | CHEMWERTH INC | ABIRATERONE ACETATE |
| 27376 | A | II | 8/1/2013 | OLON SPA | ABIRATERONE ACETATE |
| 27737 | I | II | 11/15/2013 | ICEUTICA INC | SOLUMATRIXT ABIRATERONE ACETATE DRUG PRODUCT INTERMEDIATE |
| 27829 | A | II | 12/24/2013 | MSN LABORATORIES PRIVATE LTD | ABIRATERONE ACETATE USP [ROUTE CODE - AY] |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
