Drug Master Files for: GABAPENTIN ENACARBIL
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GABAPENTIN ENACARBIL Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12736 | A | II | 11/12/1997 | TEVA PHARMACEUTICAL INDUSTRIES LTD | GABAPENTIN |
| 13178 | I | II | 9/4/1998 | MEDICHEM SA | GABAPENTIN, DRUG SUBSTANCE |
| 14024 | A | II | 3/19/1999 | FIS FABBRICA ITALIANA SINTETICI SPA | GABAPENTIN |
| 15513 | I | II | 7/3/2001 | ERREGIERRE SPA | GABAPENTIN |
| 16060 | A | II | 7/24/2002 | HIKAL LTD | GABAPENTIN |
| 16151 | A | II | 9/25/2002 | TARO PHARMACEUTICAL INDUSTRIES LTD | GABAPENTIN USP |
| 16287 | I | II | 12/4/2002 | SUN PHARMACEUTICAL INDUSTRIES LTD | GABAPENTIN USP (NON-STERILE BULK) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
