Drug Master Files for: BUMETANIDE
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BUMETANIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10994 | A | II | 7/19/1994 | OLON SPA | BUMETANIDE |
12702 | I | II | 10/15/1997 | LEO PHARMACEUTICAL PRODUCTS LTD | BUMETANIDE PURE MICRONISED |
24750 | A | II | 3/14/2011 | INDUSTRIALE CHIMICA SRL | BUMETANIDE |
33261 | A | II | 10/27/2018 | SOLARA A PHARMA SCIENCES LTD | BUMETANIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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