For partial-onset seizures. ANDA 203370, held by Torrent. Lamotrigine.
As of Nov 14, 2026, ANDA 203370 (Lamotrigine), held by Torrent, was first approved by FDA on Dec 23, 2013, with 6 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 23, 2013 | 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 | Discontinued |
| Nov 9, 2021 | Supplement 13Labeling · Standard review | Approved | None posted |
| Feb 19, 2021 | Supplement 12Labeling · Standard review | Approved | None posted |
| Nov 21, 2019 | Supplement 7Labeling · Standard review | Approved | None posted |
| Nov 21, 2019 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 25, 2017 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 25, 2017 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 23, 2013 | 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
