Drug Master Files for: ergoloid mesylates
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ergoloid mesylates Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14781 | I | II | 2/29/2000 | TEVA PHARMACEUTICAL INDUSTRIES LTD | ERGOLOID MESYLATES |
15415 | I | II | 5/4/2001 | RP SCHERER NORTH AMERICA DIV RP SCHERER CORP | HYDERGINE(ERGOLOID MESYLATES) 1MG SOFTGELS |
20626 | A | II | 6/22/2007 | EUTICALS SPA | ERGOLOID MESYLATES USP |
3022 | I | II | 9/23/1977 | LEK LJUBLJANA PHARMACEUTICAL AND CHEMICAL CO | DIHYDROERGOTOXINE METHANESULFONATE (ERGOLOID MESYLATES) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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