For partial-onset seizures. ANDA 207763, held by Zydus Pharms. Lamotrigine.
As of Nov 14, 2026, ANDA 207763 (Lamotrigine), held by Zydus Pharms, was first approved by FDA on Apr 1, 2020, with 4 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 |
|---|---|---|---|
| Apr 1, 2020 | Original application | Approved | None posted |
| 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 |
| Mar 16, 2026 | Supplement 13Labeling · Standard review | Approved | None posted |
| Mar 16, 2026 | Supplement 12Labeling · Standard review | Approved | None posted |
| Jan 8, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 10, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 1, 2020 | Original application | Approved | None posted |
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
