Drug Master Files for: treprostinil
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treprostinil Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
25548 | A | II | 12/1/2011 | ALPHORA RESEARCH INC | TREPROSTINIL SODIUM |
27680 | A | II | 10/16/2013 | YONSUNG FINE CHEMICALS CO LTD | TREPROSTINIL SODIUM |
28340 | A | II | 8/15/2016 | CHIROGATE INTERNATIONAL INC | TREPROSTINIL SODIUM |
28458 | A | II | 9/16/2014 | CHIROGATE INTERNATIONAL INC | TREPROSTINIL |
29207 | A | II | 8/12/2015 | CHIROGATE INTERNATIONAL INC | HEXADECYL TREPROSTINIL |
29915 | A | II | 10/7/2015 | CHANGZHOU BOHIV PHARMACEUTICAL TECHNOLOGY CO LTD | TREPROSTINIL INTERMEDIATE (PG14-15A) |
30000 | A | II | 12/6/2015 | MSN LABORATORIES PRIVATE LTD | TREPROSTINIL DIETHANOLAMINE [ROUTE CODE TB] |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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