Drug Master Files for: DIGOXIN
✉ Email this page to a colleague
DIGOXIN Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10067 | I | II | 1/31/1993 | PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO | DIGOXIN DRUG SUBSTANCE |
| 21559 | A | II | 4/15/2008 | BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG | DIGOXIN 20 MICROMETER |
| 2253 | I | II | 3/28/1974 | RP SCHERER CORP | DIGOXIN CAPS |
| 2277 | I | II | 5/17/1974 | ROCHE DIAGNOSTICS GMBH | DIGOXIN PRODUCTS |
| 24135 | A | II | 8/16/2010 | VITAL LABORATORIES PVT LTD | DIGOXIN |
| 24418 | A | II | 12/2/2010 | NOBILUS ENT | DIGOXIN |
| 27605 | I | II | 9/30/2013 | ALCHEM INTERNATIONAL LTD | DIGOXIN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
