Application 204667
- Type
- ANDA
- Sponsor
- SOFIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMMONIA N 13 | AMMONIA N-13 | INJECTABLE;INTRAVENOUS | 18.8mCi-188mCi/5ML (3.75-37.5mCi/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 49609-201 | Ammonia N 13 | Ammonia N-13 | SOFIE Co. | ANDA | Current |