Drug Master Files for: ergotamine tartrate
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ergotamine tartrate Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10242 | A | II | 4/26/1993 | BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG | DIHYDROERGOTAMINE MESYLATE |
14944 | A | II | 6/28/2000 | TEVA PHARMACEUTICAL INDUSTRIES LTD | DIHYDROERGOTAMINE MESYLATE |
16194 | I | II | 10/17/2002 | LEK PHARMACEUTICALS DD | DIHYDROERGOTAMINE MESYLATE |
22407 | A | II | 1/13/2009 | EUTICALS SPA | DIHYDROERGOTAMINE MESYLATE USP/EP |
22932 | A | II | 7/6/2009 | EUTICALS SPA | ERGOTAMINE TARTRATE USP/EP |
24782 | A | II | 3/23/2011 | TEVA PHARMACEUTICAL INDUSTRIES LTD | ERGOTAMINE TARTRATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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