Generated: December 16, 2017
DrugPatentWatch Database Preview
Drug Master Files for: abiraterone
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|28959||A||II||2/11/2015||SUN PHARMACEUTICAL INDUSTRIES LTD||ABIRATERONE ACETATE|
|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)|
|27376||A||II||8/1/2013||OLON SPA||ABIRATERONE ACETATE |
|27737||A||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]|
|27853||A||II||12/24/2013||HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTD||ABIRATERONE ACETATE|
|27989||A||II||2/12/2014||STERLING CHEMICAL MALTA LTD||ABIRATERONE ACETATE |
|28038||A||II||3/27/2014||DR REDDYS LABORATORIES LTD||ABIRATERONE ACETATE|
|26894||A||II||7/30/2014||CHEMWERTH INC||ABIRATERONE ACETATE|
| This preview shows a limited data set|
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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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
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