Drug Master Files for: tiagabine hydrochloride
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tiagabine hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17978 | A | II | 1/6/2005 | SUN PHARMACEUTICAL INDUSTRIES LTD | TIAGABINE HYDROCHLORIDE USP |
| 18934 | I | II | 11/4/2005 | RANBAXY LABORATORIES LTD | TIAGABINE HYDROCHLORIDE USP |
| 22033 | A | II | 9/23/2008 | CHEMWERTH INC | TIAGABINE HYDROCHLORIDE |
| 27286 | I | II | 8/26/2013 | UNICHEM LABORATORIES LTD | TIAGABINE HYDROCHLORIDE USP |
| 27380 | A | II | 12/20/2013 | SIGNA SA DE CV | TIAGABINE HYDROCHLORIDE MONOHYDRATE USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
