Drug Master Files for: ROFLUMILAST
✉ Email this page to a colleague
ROFLUMILAST Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
26764 | A | II | 12/27/2012 | SCINOPHARM TAIWAN LTD | ROFLUMILAST |
27612 | A | II | 11/30/2013 | MSN LABORATORIES PRIVATE LTD | ROFLUMILAST [ROUTE CODE - RO] |
27779 | A | II | 3/28/2014 | ALP PHARM BEIJING CO LTD | ROFLUMILAST |
28440 | A | II | 9/4/2014 | MYLAN LABORATORIES LTD | ROFLUMILAST |
28471 | A | II | 7/31/2014 | INTERQUIM SA | ROFLUMILAST |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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