AMMONIA N-13 | A204510 | PETNET SOLUTIONS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from PETNET Solutions, Inc. FDA-2023-P-2729 · 6 docket documents PETNET Solutions, Inc. filed a suitability petition on June 20, 2023, requesting approval of a Prior Approval Supplement to ANDA 204510 for Ammonia N 13 Injection, a PET drug approved under NDA 022119, to increase the strength from 3.75-37.5 mCi/mL End of Synthesis to 3.75-240 mCi/mL End of Synthesi | Suitability | 2023-07-03 | Withdrawn | PETNET Solutions, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.