Drug Master Files for: ethacrynic acid
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ethacrynic acid Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
17193 | A | II | 2/26/2004 | EGIS PHARMACEUTICALS PLC | ETHACRYNIC ACID |
25647 | A | II | 2/21/2012 | CADILA HEALTHCARE LTD | ETHACRYNIC ACID USP |
25936 | A | II | 5/29/2012 | TOPCHEM PHARMACEUTICALS LTD | ETHACRYNIC ACID |
25973 | A | II | 4/16/2012 | OLON SPA | ETHACRYNIC ACID |
26013 | A | II | 6/1/2012 | APICORE US LLC | ETHACRYNIC ACID USP |
26337 | A | II | 1/31/2013 | CHEMWERTH INC | ETHACRYNIC ACID USP NON-STERILE BULK DRUG |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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