Treats bipolar I disorder. ANDA 213271, held by Ajanta Pharma Ltd. Lamotrigine.
As of Nov 14, 2026, ANDA 213271 (Lamotrigine), held by Ajanta Pharma Ltd, was first approved by FDA on Jan 19, 2021, with 2 approved supplements and 0 published complete response letters.
Lamotrigine orally disintegrating tablets are 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 |
|---|---|---|---|
| Jan 19, 2021 | Original application | Approved | None posted |
| 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 |
| Aug 15, 2025 | Supplement 17Labeling · Standard review | Approved | None posted |
| Apr 15, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 19, 2021 | 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
