Drug Master Files for: levetiracetam
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levetiracetam Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16894 | A | II | 10/5/2003 | DIVIS LABORATORIES LTD | LEVETIRACETAM |
| 16966 | A | II | 11/17/2003 | DR REDDYS LABORATORIES LTD | LEVETIRACETAM |
| 17327 | A | II | 4/26/2004 | ESTEVE QUIMICA SA | LEVETIRACETAM |
| 17738 | A | II | 10/7/2004 | HETERO LABS LTD | LEVETIRACETAM (FORM 1) |
| 17799 | A | II | 11/2/2004 | NEULAND LABORATORIES LTD | LEVETIRACETAM USP |
| 19033 | A | II | 12/15/2005 | TEVA PHARMACEUTICAL INDUSTRIES LTD | LEVETIRACETAM |
| 19051 | I | II | 12/19/2005 | RANBAXY LABORATORIES LTD | LEVETIRACETAM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
