Drug Master Files for: tetrabenazine
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tetrabenazine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10496 | I | II | 9/24/1993 | HOFFMANN LA ROCHE INC | NITOMAN (TETRABENAZINE) TABLETS |
| 14323 | I | II | 7/25/1999 | LIFEHEALTH LTD | NITOMAN(TETRABENAZINE) TABLETS |
| 16683 | A | II | 7/3/2003 | CORDEN PHARMA CHENOVE | TETRABENAZINE |
| 24946 | I | II | 10/18/2011 | CHEMWERTH INC | TETRABENAZINE(NON-STERILE BULK DRUG SUBSTANCE) |
| 26113 | A | II | 6/4/2012 | HETERO DRUGS LTD | TETRABENAZINE |
| 26308 | A | II | 8/3/2012 | CENTAUR PHARMACEUTICALS PVT LTD | TETRABENAZINE |
| 27135 | A | II | 5/31/2013 | APOTEX PHARMACHEM INDIA PVT LTD | TETRABENAZINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
