Application 018107
- Type
- NDA
- Sponsor
- CARDINAL HEALTH 414
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MDP-BRACCO | TECHNETIUM TC-99M MEDRONATE KIT | INJECTABLE;INJECTION | N/A | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65857-505 | Kit for the Preparation of Technetium Tc 99m Medronate | technetium tc 99m medronate | Cardinal Health 414, LLC | NDA | Current |
| 65857-505 | Kit for the Preparation of Technetium Tc 99m Medronate | technetium tc 99m medronate | Cardinal Health 414, LLC | NDA | Current |
Documents
| Document | Title | Submission type | Submission no. | Date | Storage |
|---|
| 82439 | 0 | SUPPL | 17 | 2025-06-03 | Cached in FDA.report object storage |
| 82330 | 0 | SUPPL | 17 | 2025-05-27 | Cached in FDA.report object storage |
| 65221 | 0 | SUPPL | 15 | 2020-11-16 | Cached in FDA.report object storage |
| 843 | 0 | SUPPL | 11 | 2008-11-28 | Cached in FDA.report object storage |