AMMONIA N-13 | A203543 | SOFIE CO DBA SOFIE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 ANDA 203543 Orange Book re Suitability Petition from PETNET Solu... FDA-2023-P-2729 PETNET Solutions Inc filed a petition regarding ANDA 203543 concerning the suitability of a reference listed drug for the Orange Book. The petition addresses the regulatory classification and listing of the reference drug associated with this abbreviated new drug application. | Suitability | 2023-07-03 | Open | PETNET Solutions Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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