Drug Master Files for: perampanel
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perampanel Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 30391 | A | II | 6/30/2016 | TARO PHARMACEUTICAL INDUSTRIES LTD | PERAMPANEL 3/4 HYDRATE, MICRONIZED |
| 30475 | A | II | 4/21/2016 | TEVA PHARMACEUTICAL INDUSTRIES LTD | PERAMPANEL |
| 30527 | A | II | 6/2/2016 | CADILA HEALTHCARE LTD | PERAMPANEL |
| 30649 | A | II | 6/24/2016 | INTAS PHARMACEUTICALS LTD | PERAMPANEL |
| 31312 | A | II | 1/31/2017 | MSN ORGANICS PRIVATE LTD | PERAMPANEL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
