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FDA
Open for Comments
FDA-2026-P-1791
Requests that the FDA undertake a therapeutic equivalence evaluation and add a therapeutic equivalence rating for NDA 219935 Famotidine Injection in the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book)
Documents
2
Comments
0
Description
Open
Key Dates
Comment Period OpensFeb 19, 2026
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Citizen Petition
Sagent Pharmaceuticals
Requests that the FDA undertake a
therapeutic equivalence evaluation and add a
therapeutic equivalence rating for NDA 219935
Famotidine Injection in the
Approved Drug Products with
Data from Regulations.gov