Drug Master Files for: eslicarbazepine acetate
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eslicarbazepine acetate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 22026 | A | II | 9/26/2008 | BIAL PORTELA AND CA SA | ESLICARBAZEPINE ACETATE DRUG SUBSTANCE |
| 24817 | I | II | 3/31/2011 | DR REDDYS LABORATORIES LTD | ESLICARBAZEPINE ACETATE |
| 26622 | A | II | 11/19/2012 | BIAL PORTELA AND CA SA | ESLICARBAZEPINE ACETATE |
| 26927 | A | II | 3/26/2013 | JUBILANT GENERICS LTD | ESLICARBAZEPINE ACETATE |
| 30222 | A | II | 1/29/2016 | CTX LIFE SCIENCES PVT LTD | ESLICARBAZEPINE ACETATE |
| 30485 | I | II | 4/15/2016 | TIANJIN WEIJIE PHARMACEUTICAL CO LTD | ESLICARBAZEPINE ACETATE |
| 31500 | A | II | 4/3/2017 | LUPIN LTD | ESLICARBAZEPINE ACETATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
