Drug Master Files for: EPLERENONE
✉ Email this page to a colleague
EPLERENONE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
19715 | A | II | 9/8/2006 | INDUSTRIALE CHIMICA SRL | EPLERENONE |
19796 | I | II | 9/25/2006 | APOTEX PHARMACHEM INC | EPLERENONE MEK HEMISOLVATE (1:0.5) |
23466 | A | II | 1/20/2010 | MSN LABORATORIES PRIVATE LTD | EPLERENONE [ROUTE CODE: PL] |
27672 | A | II | 12/25/2013 | AURISCO PHARMACEUTICAL CO LTD | EPLERENONE |
32998 | A | II | 11/30/2018 | INDUSTRIALE CHIMICA SRL | EPLERENONE PH. EUR. |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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