ANDA 204499, held by Ipca Labs. Lamotrigine.
As of Nov 14, 2026, ANDA 204499 (Lamotrigine), held by Ipca Labs, was first approved by FDA on Sep 26, 2024, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 26, 2024 | Original application | Approved | None posted |
| Lamotrigine25MG · tablet;oral | Lamotrigine | Rx |
| Lamotrigine100MG · tablet;oral | Lamotrigine | Rx |
| Lamotrigine150MG · tablet;oral | Lamotrigine | Rx |
| Lamotrigine200MG · tablet;oral | Lamotrigine | Rx |
| Sep 3, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 26, 2024 | 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
