FAMOTIDINE | A075488 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Sagent Pharmaceuticals FDA-2026-P-1791 Sagent Pharmaceuticals submitted a citizen petition under 21 CFR 10.25(a) and 10.30 requesting that the FDA assign a therapeutic equivalence rating, specifically an "AP" code, to NDA 219935 Famotidine Injection (available in 4 mg/mL concentrations in single-dose and multi-dose vials) in the Orange B | 505(q) | 2026-02-19 | Open | Sagent Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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