Drug Master Files for: FENOLDOPAM MESYLATE
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FENOLDOPAM MESYLATE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
16145 | A | II | 9/24/2002 | SAGE CHEMICALS INC | FENOLDOPAM MESYLATE USP |
16582 | A | II | 5/12/2003 | CHEMWERTH INC | FENOLDOPAM MESYLATE (NON-STERILE BULK DRUG SUBSTANCE) |
17248 | A | II | 3/22/2004 | RELIABLE BIOPHARMACEUTICAL LLC | FENOLDOPAM MESYLATE, USP |
19636 | I | II | 6/14/2006 | EPOCH BIOSCIENCES SHENZHEN CO LTD | FENOLDOPAM MESYLATE BULK A API |
19768 | I | II | 9/2/2006 | ISOCHEM | FENOLDOPAM MESYLATE USP |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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