LAMOTRIGINE | N020241 | GLAXOSMITHKLINE LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-2144 · 6 docket documents Hyman, Phelps & McNamara, P.C., on behalf of a client, filed this suitability petition pursuant to FDC Act Section 505(j)(2)(C) requesting that FDA declare Lamotrigine Tablets in 12.5 mg (unscored) and 75 mg (scored or unscored) strengths suitable for submission in an ANDA, with GlaxoSmithKline's LA | Suitability | 2026-02-27 | Open | Hyman, Phelps & McNamara, P.C. |
Actavis Elizabeth LLC - Citizen Petition FDA-2010-P-0658 · 3 docket documents Actavis Elizabeth LLC filed this citizen petition on December 29, 2010, requesting that the FDA determine that LAMICTAL (lamotrigine) Extended-Release Tablets, 300 mg, approved under NDA 22-115, were not voluntarily withdrawn for safety or efficacy reasons, citing that the product was never commerci | 505(q) | 2011-01-14 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$12.06
per ea
Lowest NADAC/Unit
$10.28
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00173064460LAMICTAL 200 MG TABLET | $12.06 | EA | Brand | $0.0839 | 2026-06-17 |
| 00173064360LAMICTAL 150 MG TABLET | $11.47 | EA | Brand | $0.0728 | 2026-06-17 |
| 00173064255LAMICTAL 100 MG TABLET | $10.92 | EA | Brand | $0.0468 | 2026-06-17 |
| 00173063302LAMICTAL 25 MG TABLET | $10.28 | EA | Brand | $0.0283 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.