Drug Master Files for: GENENTECH INC
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GENENTECH INC Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18622 | I | II | 11/11/1993 | GENENTECH INC | TUMOR NECROSIS FACTOR RECEPTOR IMMUNOGLOBULIN G |
| 18640 | I | II | 8/21/1995 | GENENTECH INC | THROMBOPOIETIN (HUMAN, RECOMBINANT, CHO CELLS, GENENTECH) |
| 18663 | I | II | 11/9/1999 | GENENTECH INC | DORNASE ALFA INHALATION SOLUTION (GENENTECH) |
| 19630 | A | II | 6/29/2006 | GENENTECH INC | MSBA30K PEG REAGENT FOR MIRCERA (RO0503819) |
| 31796 | A | II | 8/11/2017 | GENENTECH INC | CED88004A |
| 31797 | A | II | 8/11/2017 | GENENTECH INC | CED88004S |
| 3985 | I | II | 11/21/1980 | GENENTECH INC | MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SOUTH SAN FRANCISCO. |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
