AMMONIA N-13 | N022119 | FEINSTEIN INSTITUTE MEDICAL RESEARCH
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Withdrawal Request from PETNET Solutions, Inc. FDA-2023-P-2729 PETNET Solutions, Inc. requested withdrawal of a suitability petition filed under Section 505(j)(2)(C) regarding a Prior Approval Supplement to ANDA 204510 for Ammonia N 13 Injection, which proposed changing the approved strength from 3.75-37.5 mCi/mL to 3.75-240 mCi/mL End of Synthesis. | Suitability | 2023-07-31 | Open | — |
Suitability Petition from PETNET Solutions, Inc. FDA-2023-P-2729 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 | Open | PETNET Solutions |
Attachment 1 NDA 022119 Orange Book re Suitability Petition from PETNET Solut... FDA-2023-P-2729 PETNET Solutions Inc filed a petition regarding NDA 022119 and its listing in the Orange Book, seeking a determination on the suitability of the drug product for inclusion in the FDA's patent and exclusivity database. | Suitability | 2023-07-03 | Open | PETNET Solutions Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.