Drug Master Files for: leflunomide
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leflunomide Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16038 | A | II | 6/27/2002 | FORMOSA LABORATORIES INC | LEFLUNOMIDE |
| 16109 | A | II | 8/23/2002 | CIPLA LTD | LEFLUNOMIDE USP |
| 16112 | A | II | 8/29/2002 | ALEMBIC PHARMACEUTICALS LTD | LEFLUNOMIDE USP |
| 16124 | A | II | 9/6/2002 | EMCURE PHARMACEUTICALS LTD | LEFLUNOMIDE USP |
| 16504 | I | II | 3/25/2003 | UNICHEM LABORATORIES LTD | LEFLUNOMIDE |
| 32988 | A | II | 9/7/2018 | MAPRIMED SA | LEFLUNOMIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
