Drug Master Files for: cetyl
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cetyl Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10386 | I | II | 7/30/1993 | PHARMACEUTICAL WORKS POLPHARMA SA | ACETYLSALICYLIC ACID |
| 10462 | A | II | 8/25/1993 | INDENA SPA | 10-DEACETYLBACCATIN III/R |
| 10770 | I | II | 3/11/1994 | NIPPON PROTEIN CO LTD | N-ACETYL-D-GLUCOSAMINE |
| 11063 | I | II | 9/2/1994 | PHARM ECO LABORATORIES INC | (S)-N-[2-OXO-2-(3,4,5-TRIMETHOXYPHENYL) ACETYL]PIPERIDINE-2-CARBOXYLIC ACID 1,7-BIS(3-PYRIDYL)-4-HEPTYL ESTER DICITRATE SALT |
| 11082 | I | II | 9/1/1994 | KANEKA CORPORATION JAPAN | N2-[1-(S)-ETHOXYCARBONYL 1-3-PHENYLPROPYL]-N6-TRIFLUOROACETYL-L-LYSYL-L-PROLINE. |
| 11128 | I | II | 10/5/1994 | NORISTAN LTD | ACETYLSALICYLIC ACID (ASA) |
| 11241 | I | II | 12/13/1994 | NAGASE FINE CHEMICALS LTD | 2',3',5' TRI-O-ACETYLURIDINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
