FLUOROURACIL | A076526 | TARO PHARMACEUTICAL INDUSTRIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Encube Ethicals Private Limited FDA-2019-P-2074 · 4 docket documents Encube Ethicals Private Limited filed this citizen petition requesting that the FDA designate Fluorouracil Topical Solution, 5% manufactured by Taro Pharmaceutical Industries Ltd. and approved under ANDA A076526 as the Reference Standard for the product, because the current Reference Standard EFUDEX | Other | 2019-05-10 | Granted | Encube Ethicals Private Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$4.29
per ml
Lowest NADAC/Unit
$3.38
per ml
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 51672406301FLUOROURACIL 5% TOPICAL SOLN | $4.29 | ML | Generic | — | 2026-10-21 |
| 51672406201FLUOROURACIL 2% TOPICAL SOLN | $3.38 | ML | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.