Drug Master Files for: REGADENOSON
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REGADENOSON Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 25939 | A | II | 4/2/2012 | FARMAK AS | REGADENOSON MONOHYDRATE |
| 27972 | A | II | 2/12/2014 | GLAND PHARMA LTD | REGADENOSON |
| 28939 | A | II | 12/25/2014 | SCINOPHARM TAIWAN LTD | REGADENOSON |
| 29185 | A | II | 3/31/2015 | WOCKHARDT BIO AG | REGADENOSON (AMORPHOUS) |
| 29315 | A | II | 6/23/2015 | USV PRIVATE LTD | REGADENOSON MONOHYDRATE |
| 30542 | A | II | 5/10/2016 | EUTICALS INC | REGADENOSON |
| 30834 | A | II | 9/13/2016 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | REGADENOSON |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
