Drug Master Files for: glycerol phenylbutyrate
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glycerol phenylbutyrate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10402 | I | II | 8/4/1993 | GANES CHEMICALS INC PENNSVILLE DIV | IODINATED GLYCEROL AZEO |
| 10403 | I | II | 8/4/1993 | GANES CHEMICALS INC PENNSVILLE DIV | IODINATED GLYCEROL SOLUTION |
| 10404 | I | II | 8/4/1993 | GANES CHEMICALS INC PENNSVILLE DIV | IODINATED GLYCEROL CONCENTRATE |
| 10923 | I | II | 5/25/1994 | GENZYME CORP | SN-1-PALMITOYL-2-OLEOYLPHOSPHATIDYLGLYCEROL SODIUM SALT (POPG.NA) |
| 11463 | A | II | 4/12/1995 | NOF CORP | DIMYRISTOYL PHOSPHATIDYL GLYCEROL AMMONIUM/SODIUM SALT |
| 12233 | A | IV | 11/22/1996 | CORDEN PHARMA SWITZERLAND LLC | 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOGLYCEROL, SODIUM SALT (DSPG, NA) |
| 12485 | A | II | 4/8/1997 | DYNAMIT NOBEL GMBH EXPLOSIVSTOFF UND SYSTEMTECHNIK | GLYCEROLTRINITRATE-DUROTAK 387-2516 SOLUTION |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
