Drug Master Files for: brinzolamide
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brinzolamide Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 22851 | I | II | 6/10/2009 | VIWIT PHARMACEUTICAL CO LTD | BRINZOLAMIDE USP |
| 23789 | I | II | 4/22/2010 | ALP PHARM BEIJING CO LTD | BRINZOLAMIDE USP (DRUG SUBSTANCE, NON-STERILE) |
| 25324 | I | II | 9/19/2011 | BACHEM SA | BRINZOLAMIDE |
| 25478 | A | II | 11/7/2011 | ICROM SPA | BRINZOLAMIDE (MICRONIZED AND NON MICRONIZED, STERILE AND NON STERILE) |
| 25817 | A | II | 2/22/2012 | NEULAND LABORATORIES LTD | BRINZOLAMIDE, USP |
| 25918 | A | II | 3/28/2012 | INDUSTRIALE CHIMICA SRL | BRINZOLAMIDE, USP |
| 26936 | A | II | 2/28/2013 | NEULAND LABORATORIES LTD | BRINZOLAMIDE USP (STERILE) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
