Drug Master Files for: ISOSULFAN BLUE
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ISOSULFAN BLUE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20891 | I | II | 9/27/2007 | SAFC PHARMA | ISOSULFAN BLUE |
| 21883 | A | II | 8/13/2008 | APICORE US LLC | ISOSULFAN BLUE |
| 27795 | A | II | 12/21/2013 | AUROBINDO PHARMA LTD | ISOSULFAN BLUE |
| 29829 | A | II | 9/29/2015 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | ISOSULFAN BLUE |
| 31226 | A | II | 12/6/2016 | DISHMAN CARBOGEN AMCIS LTD | ISOSULFAN BLUE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
