ANDA 77757, held by Caraco. Lamotrigine.
As of Nov 14, 2026, ANDA 77757 (Lamotrigine), held by Caraco, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 9, 2007 | Original application | Tentative approval | None posted |
| Lamotrigine25MG · tablet; oral | Lamotrigine | None (tentative approval) |
| Lamotrigine100MG · tablet; oral | Lamotrigine | None (tentative approval) |
| Lamotrigine150MG · tablet; oral | Lamotrigine | None (tentative approval) |
| Lamotrigine200MG · tablet; oral | Lamotrigine | None (tentative approval) |
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