Application 204506
- Type
- ANDA
- Sponsor
- WA UNIV SCH MED
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMMONIA N 13 | AMMONIA N-13 | INJECTABLE;INTRAVENOUS | 30mCi-300mCi/8ML (3.75-37.5mCi/ML) | No | No |
| 002 | AMMONIA N 13 | AMMONIA N-13 | INJECTABLE;INTRAVENOUS | 37.5mCi-800mCi/10ML (3.75-80mCi/ML) | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 75913-113 | Ammonia N 13 | NH3N13 | Washington University School of Medicine | ANDA | Current |
| 75913-113 | Ammonia N 13 | NH3N13 | Washington University School of Medicine | ANDA | Current |
| 75913-113 | Ammonia N 13 | NH3N13 | Washington University School of Medicine | ANDA | Current |
| 75913-113 | Ammonia N 13 | NH3N13 | Washington University School of Medicine | ANDA | Current |