IMIQUIMOD | N022483 | BAUSCH HEALTH US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Newcastle Bioscience, LLC FDA-2023-P-4281 · 7 docket documents Newcastle Bioscience, LLC filed a suitability petition requesting FDA review and approval of a proposed manufacturing process or formulation. The petition seeks the agency's determination regarding the suitability of the applicant's approach for compliance with regulatory requirements, though the sp | Suitability | 2023-10-02 | Granted | Newcastle Bioscience, LLC |
Graceway Pharmaceuticals, LLC - Citizen Petition FDA-2009-P-0423 · 17 docket documents Graceway Pharmaceuticals, LLC filed this citizen petition on August 28, 2009, requesting that the Food and Drug Administration refuse to approve any abbreviated new drug application (ANDA) under section 505(j) or new drug application (NDA) under section 505(b)(2) that references Aldara (imiquimod) 5 | 505(q) | 2010-01-20 | Denied | — |
Graceway Pharmaceuticals, LLC - Citizen Petition FDA-2009-P-0364 · 8 docket documents Graceway Pharmaceuticals, LLC filed this citizen petition under 21 USC 355 and 21 CFR 10.30 requesting that FDA refuse to approve any abbreviated new drug application for a generic imiquimod cream product referencing Graceway's Aldara (imiquimod) Cream, 5%, unless the application contains comparativ | 505(q) | 2009-08-06 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$111.43
per gm
Lowest NADAC/Unit
$111.43
per gm
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00093313331IMIQUIMOD 3.75% CREAM PUMP | $111.43 | GM | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.