HYDROXYUREA | N016295 | WAYLIS THERAPEUTICS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from McKenna & Cuneo LLP FDA-1998-P-1134 · 7 docket documents McKenna & Cuneo LLP, on behalf of a pharmaceutical client, submitted this petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting authorization to file an abbreviated new drug application (ANDA) for a hydroxyurea scored tablet 1000 mg product, which would differ fr | Other | 2017-04-12 | Granted | McKenna & Cuneo LLP |
Citizen Petition from Duramed Pharmaceuticals, Inc. FDA-1996-P-0107 · 2 docket documents Duramed Pharmaceuticals, Inc. submitted this petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA permit acceptance of an Abbreviated New Drug Application for a 250 mg capsule strength of Hydroxyurea Capsules and amend the suitability list to include | Other | 2009-06-10 | Open | Duramed Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.7817
per ea
Lowest NADAC/Unit
$0.7283
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 61269040460DROXIA 400 MG CAPSULE | $0.7817 | EA | Brand | — | 2025-09-17 |
| 61269040260DROXIA 200 MG CAPSULE | $0.7291 | EA | Brand | — | 2025-09-17 |
| 61269040360DROXIA 300 MG CAPSULE | $0.7283 | EA | Brand | — | 2025-09-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.