Drug Master Files for: DIAZOXIDE
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DIAZOXIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
16819 | I | II | 9/2/2003 | TRANSO PHARM PRODUKTIONS GMBH | DIAZOXIDE |
31249 | A | II | 1/27/2017 | NOVITIUM PHARMA LLC | DIAZOXIDE USP |
32335 | A | II | 12/16/2017 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | DIAZOXIDE |
32771 | A | II | 5/7/2018 | GUANG'AN KINGDAY PHARMA AND CHEM CO LTD | DIAZOXIDE USP |
7031 | A | II | 6/22/1987 | LUNDBECK PHARMACEUTICALS ITALY SPA | DIAZOXIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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