Drug Master Files for: MACITENTAN
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MACITENTAN Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
30212 | A | II | 1/30/2016 | MSN LIFE SCIENCES PRIVATE LTD | MACITENTAN [ROUTE CODE IM] |
30969 | A | II | 9/30/2016 | MYLAN LABORATORIES LTD | MACITENTAN |
31179 | A | II | 12/13/2016 | RAKS PHARMA PVT LTD | MACITENTAN |
31213 | A | II | 1/5/2017 | HONOUR LAB LTD | MACITENTAN |
31416 | A | II | 4/13/2017 | TEVA PHARMACEUTICAL INDUSTRIES LTD | MACITENTAN |
31463 | A | II | 4/1/2017 | CADILA HEALTHCARE LTD | MACITENTAN |
31658 | A | II | 5/31/2017 | SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD | MACITENTAN |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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