Drug Master Files for: PHYTONADIONE
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PHYTONADIONE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
26447 | A | II | 9/26/2012 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | PHYTONADIONE |
26654 | A | II | 11/19/2012 | G AND A ASSOCS LLC | PHYTONADIONE USP, NON STERILE, BULK DRUG |
27805 | A | II | 12/28/2013 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | PHYTONADIONE ROUTE-B |
29669 | A | II | 9/30/2015 | MSN LABORATORIES PRIVATE LTD | PHYTONADIONE USP [ROUTE CODE HN] |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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