Drug Master Files for: milrinone
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milrinone Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
13195 | A | II | 9/23/1998 | CHEMWERTH INC | MILRINONE, NON-STERILE BULK DRUG |
13806 | I | II | 10/30/1998 | APTUIT INC | MILRINONE DRUG SUBSTANCE |
14023 | I | II | 3/9/1999 | BOEHRINGER INGELHEIM CHEMICALS INC | MILRINONE |
14319 | A | II | 7/1/1999 | FARMHISPANIA SA | MILRINONE |
14375 | A | II | 8/31/1999 | ALBEMARLE CORP | MILRINONE USP |
19709 | I | II | 8/28/2006 | SAI LIFE SCIENCES LTD | MILRINONE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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