Drug Master Files for: AMGEN INC
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AMGEN INC Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18672 | I | II | 4/2/2001 | AMGEN INC | HUMAN MONOCLONAL ANTIBODY (MDX-015)(SP2/0,- AG14 CELLS, MEDAREX) TO IL15 |
| 21000 | A | V | 11/12/2007 | AMGEN INC | AML ASEPTIC PROCESSING WAREHOUSING AND LABORATORIES |
| 22171 | I | V | 11/11/2008 | AMGEN INC | PRODUCTION MODULE 2 (PM2) ASEPTIC FACILITY LOCATED CO. DUBLIN, IRELAND |
| 29873 | A | II | 11/6/2015 | AMGEN INC | AMG 191 DRUG SUBSTANCE |
| 29877 | A | II | 11/6/2015 | AMGEN INC | AMG 191 CELL LINE DEVELOPMENT |
| 29883 | A | II | 11/6/2015 | AMGEN INC | AMG 191 DRUG PRODUCT |
| 30198 | A | II | 2/22/2016 | AMGEN INC | AMG 282 DRUG SUBSTANCE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
