Drug Master Files for: teriflunomide
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teriflunomide Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 27860 | A | II | 1/29/2014 | MSN LABORATORIES PRIVATE LTD | TERIFLUNOMIDE [ROUTE CODE TO] |
| 28898 | A | II | 3/16/2016 | ALEMBIC PHARMACEUTICALS LTD | TERIFLUNOMIDE |
| 28991 | A | II | 3/20/2015 | GLENMARK PHARMACEUTICALS LTD | TERIFLUNOMIDE |
| 29701 | A | II | 10/1/2015 | HONOUR LAB LTD | TERIFLUNOMIDE |
| 29705 | A | II | 9/29/2015 | UNICHEM LABORATORIES LTD | TERIFLUNOMIDE |
| 29802 | A | II | 9/29/2015 | MEGAFINE PHARMA P LTD | TERIFLUNOMIDE DRUG SUBSTANCE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
