Drug Master Files for: GENZYME CORP
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GENZYME CORP Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10101 | I | II | 2/25/1993 | GENZYME CORP | CERAMIDETRIHEXOSIDASE |
| 10375 | I | II | 7/26/1993 | GENZYME CORP | MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LIESTAL, SWITZERLAND. |
| 10556 | I | II | 9/30/1993 | GENZYME CORP | SODIUM CHOLESTERYL SULPHATE |
| 10923 | I | II | 5/25/1994 | GENZYME CORP | SN-1-PALMITOYL-2-OLEOYLPHOSPHATIDYLGLYCEROL SODIUM SALT (POPG.NA) |
| 10996 | I | II | 7/21/1994 | GENZYME CORP | 5-METHYLSULFONAMIDOINDOLE-2-CARBOXYLIC ACID |
| 13725 | I | II | 9/1/1998 | GENZYME CORP | CLINDAMYCIN PHOSPHATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
