Application 204530
- Type
- ANDA
- Sponsor
- HOT SHOTS NM LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM FLUORIDE F-18 | SODIUM FLUORIDE F-18 | INJECTABLE;INTRAVENOUS | 10-200mCi/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 76419-211 | Sodium Fluoride F 18 | SODIUM FLUORIDE F-18 | Hot Shots NM, LLC dba Midwest Positron Technology, LC | ANDA | Current |
| 76419-211 | Sodium Fluoride F 18 | SODIUM FLUORIDE F-18 | Hot Shots NM, LLC dba Midwest Positron Technology, LC | ANDA | Current |