Treats bipolar I disorder. ANDA 219677, held by Taro. Lamotrigine.
As of Nov 14, 2026, ANDA 219677 (Lamotrigine), held by Taro, was first approved by FDA on Oct 7, 2025, with 1 approved supplement and 0 published complete response letters.
Lamotrigine is indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 7, 2025 | Original application | Approved |
| Lamotrigine25MG · tablet, orally disintegrating;oral | Lamotrigine | Rx |
| Lamotrigine50MG · tablet, orally disintegrating;oral | Lamotrigine | Rx |
| Lamotrigine100MG · tablet, orally disintegrating;oral | Lamotrigine | Rx |
| Lamotrigine200MG · tablet, orally disintegrating;oral | Lamotrigine | Rx |
| Jul 13, 2026 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 7, 2025 | 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
