Application 212155
- Type
- NDA
- Sponsor
- ZIONEXA US CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CERIANNA | FLUOROESTRADIOL F18 | INJECTABLE;INJECTION | 148MBQ/ML TO 3700MBQ/ML(4MCI/ML TO 100MCI/ML) | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72874-001 | CERIANNA | Fluoroestradiol F 18 | Zionexa US Corporation | NDA | Current |
| 72874-001 | CERIANNA | Fluoroestradiol F 18 | Zionexa US Corporation | NDA | Current |
| 72874-001 | CERIANNA | Fluoroestradiol F 18 | Zionexa US Corporation | NDA | Current |
| 72874-001 | CERIANNA | Fluoroestradiol F 18 | Zionexa US Corporation | NDA | Current |
| 72874-001 | CERIANNA | Fluoroestradiol F 18 | Zionexa US Corporation | NDA | Current |
| 72874-001 | CERIANNA | Fluoroestradiol F 18 | Zionexa US Corporation | NDA | Current |
| 72874-001 | CERIANNA | Fluoroestradiol F 18 | Zionexa US Corporation | NDA | Current |
| 72874-001 | CERIANNA | Fluoroestradiol F 18 | Zionexa US Corporation | NDA | Current |
| 72874-001 | CERIANNA | Fluoroestradiol F 18 | Zionexa US Corporation | NDA | Current |
| 72874-001 | CERIANNA | Fluoroestradiol F 18 | Zionexa US Corporation | NDA | Current |
| 72874-001 | CERIANNA | Fluoroestradiol F 18 | Zionexa US Corporation | NDA | Current |
| 72874-001 | CERIANNA | Fluoroestradiol F 18 | Zionexa US Corporation | NDA | Current |
| 72874-001 | CERIANNA | Fluoroestradiol F 18 | Zionexa US Corporation | NDA | Current |
| 72874-001 | CERIANNA | Fluoroestradiol F 18 | Zionexa US Corporation | NDA | Current |