Drug Master Files for: CARBAMAZEPINE
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CARBAMAZEPINE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11901 | I | II | 3/26/1996 | ARZNEIMITTELWERK DRESDEN GMBH | CARBAMAZEPINE |
| 12512 | I | II | 5/21/1997 | MAX INDIA LTD | CARBAMAZEPINE BULK DRUG SUBSTANCE |
| 13125 | I | II | 8/11/1998 | TEVA GROUP | CARBAMAZEPINE USP |
| 14410 | A | II | 9/21/1999 | JUBILANT GENERICS LTD | CARBAMAZEPINE USP |
| 14893 | I | II | 5/19/2000 | ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD | CARBAMAZEPINE USP |
| 15195 | A | II | 12/4/2000 | SIEGFRIED EVIONNAZ SA | CARBAMAZEPINE (CARBATOL) |
| 19914 | I | II | 10/25/2006 | ALDRICH CHEMICAL CO ISOTEC FACILITY | CARBAMAZEPINE-13C1, 15N1 FOR CLINICAL RESEARCH |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
