Application 204366
- Type
- ANDA
- Sponsor
- SHERTECH LABS LLC
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16129-003 | Ammonia | AMMONIA N-13 | Shertech Laboratories, LLC | ANDA | Current |
| 16129-003 | Ammonia | AMMONIA N-13 | Shertech Laboratories, LLC | ANDA | Current |
| 16129-003 | Ammonia | AMMONIA N-13 | Shertech Laboratories, LLC | ANDA | Current |
| 16129-003 | Ammonia | AMMONIA N-13 | Shertech Laboratories, LLC | ANDA | Current |
| 16129-003 | Ammonia | AMMONIA N-13 | Shertech Laboratories, LLC | ANDA | Current |