Drug Master Files for: rose
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rose Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10109 | A | II | 2/23/1993 | IPCA LABORATORIES LTD | FUROSEMIDE USP |
| 11059 | A | II | 9/1/1994 | ROQUETTE AMERICA INC | DEXTROSE MONOHYDRATE, USP GRADE |
| 11342 | A | V | 2/13/1995 | FRESENIUS KABI USA LLC | MANUFACTURING FACILITY IN MELROSE PARK, IL |
| 11364 | A | IV | 3/2/1995 | SYMRISE INC | MICROSEAL NATURAL AND ARTIFICIAL ORANGE FLAVOR 9/79J839 |
| 11403 | I | V | 3/27/1995 | APP PHARMACEUTICALS LLC | TERMINAL STERILZATION PROGRAM IN MELROSE PARK, ILLINOIS. |
| 11533 | I | II | 5/25/1995 | TORONTO RESEARCH CHEMICALS INC | SUCROSE OCTASULFATE, POTASSIUM SALT |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
