Drug Master Files for: TOFACITINIB CITRATE
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TOFACITINIB CITRATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 27721 | A | II | 11/30/2013 | MSN LABORATORIES PRIVATE LTD | TOFACITINIB CITRATE [ROUTE CODE - TT] |
| 29002 | A | II | 3/11/2015 | GLENMARK PHARMACEUTICALS LTD | TOFACITINIB CITRATE |
| 30531 | A | II | 6/4/2016 | CADILA HEALTHCARE LTD | TOFACITINIB CITRATE |
| 30554 | A | II | 5/19/2016 | SINTENOVO SA DE CV | TOFACITINIB CITRATE |
| 30578 | A | II | 6/13/2016 | QILU TIANHE PHARMACEUTICAL CO LTD | TOFACITINIB CITRATE (NON-STERILE API) |
| 30617 | A | II | 8/2/2016 | SUN PHARMACEUTICAL INDUSTRIES LTD | TOFACITINIB CITRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
