Drug Master Files for: CABERGOLINE
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CABERGOLINE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15423 | A | II | 4/30/2001 | FINETECH PHARMACEUTICAL LTD | CABERGOLINE DRUG SUBSTANCE |
| 15933 | I | II | 3/18/2002 | IVAX CR | CABERGOLINE |
| 18113 | A | II | 2/21/2005 | TEVA PHARMACEUTICAL INDUSTRIES LTD | CABERGOLINE |
| 18199 | I | II | 3/21/2005 | GEDEON RICHTER PLC | CABERGOLINE |
| 18972 | I | II | 11/25/2005 | RESOLUTION CHEMICALS LTD | CABERGOLINE DRUG SUBSTANCE |
| 22620 | I | II | 3/13/2009 | APOTEX PHARMACHEM INDIA PVT LTD | CABERGOLINE USP |
| 23918 | A | II | 12/29/2010 | APICORE US LLC | CABERGOLINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
