Drug Master Files for: HYDROXYUREA
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HYDROXYUREA Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 1077 | I | II | 8/25/1967 | ER SQUIBB AND SONS INC | MANUFACTURE OF HYDROXYUREA |
| 11899 | A | II | 3/25/1996 | OLON SPA | HYDROXYUREA |
| 12754 | A | II | 11/14/1997 | EUTICALS SPA | HYDROXYUREA |
| 16458 | I | II | 2/21/2003 | CHEMSPEC | HYDROXYUREA |
| 20615 | A | II | 6/15/2007 | QILU TIANHE PHARMACEUTICAL CO LTD | HYDROXYUREA USP (NON-STERILE BULK) |
| 2258 | I | II | 4/9/1974 | FERMENTA FRANCE SA | HYDROXYUREA BY OLMACO OF EMPERNON,FRANCE (FORMERLY HELD BY OLMACO) |
| 2259 | I | II | 4/11/1974 | SQUIBB | 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
