Drug Master Files for: dimethyl fumarate
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dimethyl fumarate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 1067 | I | II | 6/29/1967 | ARAPAHOE CHEMICALS INC DIV SYNTEX LABORATORIES INC | DIMETHYL SULFOXIDE |
| 10756 | I | II | 2/28/1994 | RAYLO CHEMICALS | INTERMEDIATE FOR ACA-147, 4-(2,2-DIMETHYLPROPYL)-N-HEXYLBENZENEMETHANAMINE HYDROCHLORIDE |
| 11727 | A | II | 10/31/1995 | KOEI CHEMICAL CO LTD | BOC-PIPERAZINE (S)-3-[[(1,1-DIMETHYLETHYL) AMINO] CARBONYL] -1- PIPERAZINECARBOXYLIC ACID 1,1-DIMETHYLETHYL ESTER |
| 12028 | I | II | 7/8/1996 | MICROBIOPHARM JAPAN CO LTD | (1S,3R)-1,3-BIS(TERT-BUTYLDIMETHYLSILYLOXY) ANDROST-5-EN-17-ONE (SI-HDEA) |
| 1214 | I | II | 8/1/1968 | TROPONWERKE GMBH CO KG | PHENTERMINE (C.A. NAME,-DIMETHYLPHENETHYLAMINE) |
| 12706 | A | II | 10/20/1997 | GAYLORD CHEMICAL CO LLC | DIMETHYL SULFOXIDE (DMSO), USP GRADE |
| 14335 | A | II | 8/6/1999 | KATWIJK CHEMIE BV | 1,2-DIMETHYL-3-HYDROXY-PYRIDONE-4(DEFERIPONE) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
