CLONAZEPAM | N017533 | CHEPLAPHARM ARZNEIMITTEL GMBH
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-1808 · 5 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that the FDA determine whether Klonopin (clonazepam) Tablets, 0.25 mg, approved under NDA 017533 and held by Cheplapharm Arzneimittel GmbH, was voluntarily withdrawn for reasons of safety or effectiveness, with the petitioner asse | 505(q) | 2025-06-23 | Granted | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2003-P-0122 · 8 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Clonazepam Oral Solution, 1 mg per 5 mL suitable for submission as an abbreviated new drug application under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, with Klonopin Tabl | Other | 2023-02-24 | Granted | Lachman Consultant Services, Inc. |
Citizen Petition from Emily Robin et al FDA-2010-P-0091 · 6 docket documents Emily Robin and other individuals who experienced adverse reactions to benzodiazepines filed this petition requesting that the FDA amend labeling for all FDA-approved benzodiazepines, including Ativan (lorazepam), Xanax (alprazolam), Klonopin (clonazepam), and Valium (diazepam), to standardize warni | Other | 2010-03-01 | Denied | Emily Robin et al |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$4.26
per ea
Lowest NADAC/Unit
$2.68
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 61269062010KLONOPIN 2 MG TABLET | $4.26 | EA | Brand | $0.0378 | 2026-04-01 |
| 61269061010KLONOPIN 1 MG TABLET | $3.06 | EA | Brand | $0.0250 | 2026-04-01 |
| 61269060510KLONOPIN 0.5 MG TABLET | $2.68 | EA | Brand | $0.0199 | 2026-04-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.