Application 209607
- Type
- NDA
- Sponsor
- PROGENICS PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AZEDRA | IOBENGUANE I-131 | SOLUTION;INTRAVENOUS | 15mCi/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71258-015 | Azedra | iobenguane I-131 | Progenics Pharmaceuticals, Inc. | NDA | Current |
| 71258-015 | Azedra | iobenguane I-131 | Progenics Pharmaceuticals, Inc. | NDA | Current |
| 71258-015 | Azedra | iobenguane I-131 | Progenics Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73510 | SUPPL | 2023-02-16 |
| 73511 | SUPPL | 2023-02-15 |
| 56703 | ORIG | 2018-12-11 |
| 55084 | ORIG | 2018-08-03 |
| 55045 | ORIG | 2018-07-30 |