KETOCONAZOLE | A075581 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Arent Fox LLP FDA-2018-P-4812 · 4 docket documents Arent Fox LLP, on behalf of an unnamed client, filed this citizen petition on December 19, 2018, requesting that the FDA Commissioner determine whether Nizoral Cream (Ketoconazole 2% topical cream), NDA No. N019084, held by Janssen Pharmaceutical Products, was voluntarily withdrawn from the commerci | 505(q) | 2018-12-20 | Granted | Arent Fox LLP |
Citizen Petition from Teligent Pharma, Inc. FDA-2017-P-3468 · 5 docket documents Teligent Pharma, Inc. filed a citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate either Ketoconazole Cream 2% ANDA 076294 held by Fougera Pharmaceuticals, Inc. or KETOZOLE Cream 2% ANDA 075638 held by Taro Pharmaceuticals USA, Inc. as | 505(q) | 2017-06-02 | Denied | Teligent Pharma, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.3107
per gm
Lowest NADAC/Unit
$0.1633
per gm
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00093321915KETOCONAZOLE 2% CREAM | $0.3107 | GM | Generic | — | 2026-06-17 |
| 00093321930KETOCONAZOLE 2% CREAM | $0.2562 | GM | Generic | — | 2026-06-17 |
| 00093321992KETOCONAZOLE 2% CREAM | $0.1633 | GM | Generic | — | 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.