Application 209507
- Type
- ANDA
- Sponsor
- UNIV TX SW MEDCTR
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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70681-001 | Ammonia | AMMONIA N-13 | The University of Texas Southwestern Medical Center | ANDA | Current |
| 70681-001 | Ammonia | AMMONIA N-13 | The University of Texas Southwestern Medical Center | ANDA | Current |
| 70681-001 | Ammonia | AMMONIA N-13 | University of Texas Southwestern Medical Center, The | ANDA | Current |