Treats bipolar I disorder. ANDA 76701, held by Dr Reddys Labs Ltd. Lamotrigine.
As of Nov 14, 2026, ANDA 76701 (Lamotrigine), held by Dr Reddys Labs Ltd, was first approved by FDA on Jan 22, 2009, with 8 approved supplements and 0 published complete response letters.
Lamotrigine tablet (chewable, dispersible) is indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older partial-onset seizures. primary generalized tonic-clonic 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 AED. 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 22, 2009 | Original application | Approved |
| Lamotrigine5MG · tablet, for suspension;oral | Lamotrigine | Rx |
| Lamotrigine25MG · tablet, for suspension;oral | Lamotrigine | Rx |
| Nov 30, 2016 | Supplement 8Labeling · Standard review | Approved | None posted |
| Mar 15, 2012 | Supplement 5Labeling | Approved | None posted |
| Mar 15, 2012 | Supplement 7Labeling | Approved | None posted |
| Sep 29, 2011 | Supplement 6Labeling | Approved | None posted |
| Jan 12, 2011 | Supplement 4Labeling | Approved | None posted |
| Feb 23, 2010 | Supplement 3Labeling | Approved | None posted |
| Sep 21, 2009 | Supplement 1Labeling | Approved | None posted |
| Sep 21, 2009 | Supplement 2Labeling | Approved | None posted |
| Jan 22, 2009 | 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
