Drug Master Files for: isosorbide mononitrate
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isosorbide mononitrate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 1021 | I | II | 1/12/1967 | NYSCO LABS INC | ISOSORBIDE DINITRATE TIMED RELEASE PELLETS |
| 10823 | I | II | 3/18/1994 | DOTTIKON EXCLUSIVE SYNTHESIS AG | ISOSORBIDE-5-NITRATE EXTENDED RELEASE PREMIXTURE 49.2% |
| 12564 | I | II | 6/25/1997 | SELOC AG | ISOSORBIDE CONCENTRATE |
| 12679 | I | II | 10/2/1997 | CAMBREX KARLSKOGA AB | ISOSORBIDE-5-MONONITRATE/LACTOSE |
| 1429 | I | II | 3/3/1969 | VICTOR M HERMELIN CO DIV K-V PHARMACAL CO | ISORDIL TEMBIDS (ISOSORBIDE DINITRATE) SRC |
| 1791 | I | II | 9/13/1971 | NAPP-LEMKE CHEMS INC | ISOSORBIDE DINITRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
