Drug Master Files for: GILEAD SCIENCES INC
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GILEAD SCIENCES INC Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12688 | I | II | 10/7/1997 | GILEAD SCIENCES INC | PMPA GEL |
| 15661 | I | II | 10/12/2001 | GILEAD SCIENCES INC | FK506LC AND PLACEBO |
| 16033 | I | II | 6/28/2002 | GILEAD SCIENCES INC | LIPOSOMAL OSI-7904 FOR INJECTION (OSI-7904L) |
| 16237 | I | II | 11/6/2002 | GILEAD SCIENCES INC | LIPOSOMAL LURTOTECAN FOR INJECTION (OSI-211) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
