LEVETIRACETAM | N021505 | UCB INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consultant Services, Inc. FDA-2026-P-2354 · 6 docket documents Lachman Consultant Services, Inc., on behalf of a client, filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to proceed with an Abbreviated New Drug Application for Levetiracetam Powder for Oral Solution in strengths of 250 mg, | Suitability | 2026-03-06 | Open | Lachman Consultant Services, Inc. |
Nexus Pharmaceuticals, Inc. - Citizen Petition FDA-2011-P-0186 · 5 docket documents Nexus Pharmaceuticals, Inc. filed this suitability petition requesting that the FDA declare Levetiracetam Injection 1000 mg/Vial suitable for submission as an Abbreviated New Drug Application under section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act, with the reference listed drug being | Other | 2011-04-04 | Open | — |
The Weinberg Group, Inc. - Citizen Petition FDA-2009-P-0285 · 5 docket documents The Weinberg Group Inc. filed a suitability petition on June 19, 2009, requesting that the FDA declare Levetiracetam Extended-Release Tablets in 1000 mg and 1500 mg strengths suitable for submission as an ANDA, with the reference listed drug being Keppra XR 750 mg approved under NDA 22-285, arguing | Other | 2009-06-23 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.92
per ml
Lowest NADAC/Unit
$1.92
per ml
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 50474000148KEPPRA 100 MG/ML ORAL SOLN | $1.92 | ML | Brand | $0.0301 | 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.