DrugPatentWatch Database Preview
Drug Master Files for: UREA
UREA Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10161 | I | II | 3/23/1993 | PERKIN ELMER LIFE SCIENCES | [14C]-UREA |
| 1077 | I | II | 8/25/1967 | ER SQUIBB AND SONS INC | MANUFACTURE OF HYDROXYUREA |
| 11378 | A | II | 3/16/1995 | CAMBRIDGE ISOTOPE LABORATORIES INC | 13C UREA |
| 11455 | A | II | 4/17/1995 | ALDRICH CHEMICAL CO | UREA-13 C |
| 11685 | I | II | 4/20/1995 | SYNTHELABO PHARMACIE | UREA-CALCIUM ACETYLSALICYLATE |
| 11899 | A | II | 3/25/1996 | OLON SPA | HYDROXYUREA |
| 12754 | A | II | 11/14/1997 | EUTICALS SPA | HYDROXYUREA |
| 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
