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Nonrulemaking
FDA
Open for Comments
FDA-2026-P-2144
Requests that the FDA declare that the drug products Lamotrigine Tablets, 12.5 mg (unscored) and 75 mg (scored or unscored), are suitable for consideration in an Abbreviated New Drug Application.
Documents
6
Comments
0
Key Dates
Comment Period OpensFeb 27, 2026
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Suitability Petition
Hyman Phelps and McNamara PC
declare
that the drug products Lamotrigine Tablets
12 5 mg unscored
and 75 mg scored or unscored
are suitable for consideration in an
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