Application 205687
- Type
- ANDA
- Sponsor
- ESSENTIAL ISOTOPES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMMONIA N 13 | AMMONIA N-13 | INJECTABLE;INTRAVENOUS | 3.75-260mCi/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51760-003 | Ammonia N 13 | NH3N13 | Essential Isotopes | ANDA | Current |
| 51760-003 | Ammonia N 13 | NH3N13 | Essential Isotopes | ANDA | Current |
| 51760-003 | Ammonia N 13 | NH3N13 | Essential Isotopes | ANDA | Current |
| 51760-003 | Ammonia N 13 | NH3N13 | Essential Isotopes | ANDA | Current |
| 51760-003 | Ammonia N 13 | NH3N13 | Essential Isotopes | ANDA | Current |