Drug Master Files for: CEPHALEXIN
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CEPHALEXIN Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13210 | A | II | 4/30/1998 | DSM SINOCHEM PHARMACEUTICALS NETHERLANDS BV | CEPHALEXIN MONOHYDRATE |
| 13385 | I | II | 9/1/1998 | LILLY RESEARCH LABORATORIES | CEPHALEXIN MONOHYDRATE |
| 13519 | I | II | 9/1/1998 | LARK | CEPHALEXIN MONOHYDRATE |
| 13534 | I | II | 9/1/1998 | ISF | CEPHALEXIN MONOHYDRATE |
| 13564 | I | II | 9/1/1998 | ANTIBIOTICOS | CEPHALEXIN MONOHYDRATE |
| 13588 | A | II | 9/1/1998 | ANTIBIOTICOS SA | CEPHALEXIN MONOHYDRATE |
| 13610 | I | II | 9/1/1998 | DISTA PRODUCTS CO DIV ELI LILLY AND CO | CEPHALEXIN |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
