Application 125327
- Type
- BLA
- Sponsor
- BTG INTERNATIONAL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VORAXAZE | GLUCARPIDASE | INJECTABLE; INJECTION | 1000 UNITS PER VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50633-210 | Voraxaze | glucarpidase | BTG International Inc. | BLA | Current |
| 50633-210 | Voraxaze | glucarpidase | BTG International Inc. | BLA | Current |
| 50633-210 | Voraxaze | glucarpidase | BTG International Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 59722 | SUPPL | 2019-08-15 |
| 59695 | SUPPL | 2019-08-14 |
| 31936 | SUPPL | 2013-04-01 |
| 18875 | SUPPL | 2013-04-01 |
| 22802 | ORIG | 2012-03-07 |
| 31935 | ORIG | 2012-01-20 |
| 39932 | ORIG | 2012-01-17 |