Application 018107
- Type
- NDA
- Sponsor
- CARDINAL HEALTH 414
Application Products#
Product, Drug, Ingredient table| 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 table| 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, Submission type, Date table| Document | Submission type | Date |
|---|
| 82439 | SUPPL | 2025-06-03 |
| 82330 | SUPPL | 2025-05-27 |
| 65221 | SUPPL | 2020-11-16 |
| 843 | SUPPL | 2008-11-28 |