Drug Master Files for: ergocalciferol
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ergocalciferol Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11142 | A | II | 10/18/1994 | SYNTHESIA AS | ERGOCALCIFEROL USP |
15533 | A | II | 7/13/2001 | CATALENT PHARMA SOLUTIONS LLC | DRISDOL SOFTGELS (ERGOCALCIFEROL, 50, 000 IU) |
21839 | I | II | 5/30/2008 | SYNTHESIA AS | ERGOCALCIFEROL |
23155 | I | II | 9/18/2009 | ALP PHARM BEIJING CO LTD | ERGOCALCIFEROL USP |
23727 | A | II | 1/5/2010 | SICHUAN NEIJIANG HUIXIN PHARMACEUTICAL CO LTD | VITAMIN D2 (ERGOCALCIFEROL) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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