Drug Master Files for: DICLOFENAC EPOLAMINE
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DICLOFENAC EPOLAMINE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10360 | I | II | 7/14/1993 | IROTEC LABORATORIES | DICLOFENAC SODIUM |
| 10831 | A | II | 3/24/1994 | YUNG ZIP CHEMICAL IND CO LTD | DICLOFENAC POTASSIUM |
| 11267 | A | II | 12/23/1994 | OLON SPA | DICLOFENAC POTASSIUM |
| 11499 | I | II | 5/11/1995 | ASSIA CHEMICAL INDUSTRIES LTD | DICLOFENAC SODIUM |
| 11676 | I | II | 9/26/1995 | AMOLI ORGANICS LTD | DICLOFENAC SODIUM |
| 11700 | I | II | 9/30/1995 | FARCHEMIA SRL | DICLOFENAC SODIUM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
