Application 202153
- Type
- NDA
- Sponsor
- JUBILANT DRAXIMAGE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RUBY-FILL | RUBIDIUM CHLORIDE RB-82 | SOLUTION;INTRAVENOUS | N/A | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65174-021 | RUBY-FILL | Rubidium Rb 82 | Jubilant DraxImage Inc. | NDA | Current |
| 65174-021 | RUBY-FILL | Rubidium Rb 82 | Jubilant DraxImage Inc. | NDA | Current |
| 65174-021 | RUBY-FILL | Rubidium Rb 82 | Jubilant DraxImage Inc. | NDA | Current |
| 65174-021 | RUBY-FILL | Rubidium Rb 82 | Jubilant DraxImage Inc., dba Jubilant Radiopharma | NDA | Current |
| 65174-021 | RUBY-FILL | Rubidium Rb 82 | Jubilant DraxImage Inc. | NDA | Current |
| 65174-021 | RUBY-FILL | Rubidium Rb 82 | Jubilant DraxImage Inc., dba Jubilant Radiopharma | NDA | Current |
| 65174-125 | RUBY-FILL | Rubidium Rb 82 | Jubilant DraxImage Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 58474 | SUPPL | 2019-04-30 |
| 58468 | SUPPL | 2019-04-26 |
| 47130 | ORIG | 2017-02-08 |
| 45587 | ORIG | 2016-10-24 |
| 45553 | ORIG | 2016-10-05 |