Drug Master Files for: BRIMONIDINE TARTRATE
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BRIMONIDINE TARTRATE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
15585 | A | II | 8/15/2001 | FARMAK AS | BRIMONIDINE TARTRATE |
15601 | A | II | 8/27/2001 | MEDICHEM SA | BRIMONIDINE TARTRATE |
17588 | A | II | 8/5/2004 | PIRAMAL ENTERPRISES LTD | BRIMONIDINE TARTRATE |
20855 | A | II | 9/17/2007 | FDC LTD | BRIMONIDINE TARTRATE |
22166 | A | II | 10/29/2008 | INDOCO REMEDIES LTD | BRIMONIDINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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