For partial-onset seizures. ANDA 201374, held by Ph Health. Lamotrigine.
As of Nov 14, 2026, ANDA 201374 (Lamotrigine), held by Ph Health, was first approved by FDA on Dec 26, 2012, with 2 approved supplements and 0 published complete response letters.
Lamotrigine extended-release tablets are indicated for: adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 26, 2012 | Original application | Approved |
| Lamotrigine25MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine50MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine100MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine200MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine250MG · tablet, extended release;oral | Lamotrigine | Rx |
| Lamotrigine300MG · tablet, extended release;oral | Lamotrigine | Rx |
| Feb 7, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 7, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 26, 2012 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
