Application 018124
- Type
- NDA
- Sponsor
- PHARMALUCENCE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CIS-MDP | TECHNETIUM TC-99M MEDRONATE KIT | INJECTABLE;INJECTION | N/A | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45567-0040 | Kit for the Preparation of Technetium Tc 99M Medronate | TC 99M MEDRONATE | Pharmalucence, Inc. | NDA | Current |
| 45567-0040 | Kit for the Preparation of Technetium Tc 99M Medronate | TC 99M MEDRONATE | Pharmalucence, Inc. | NDA | Current |
| 45567-0040 | Kit for the Preparation of Technetium Tc 99M Medronate | TC 99M MEDRONATE | Sun Pharmaceutical Industries, Inc. | NDA | Current |