KETOCONAZOLE | A075319 | TARO PHARMACEUTICAL INDUSTRIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from B&H Consulting Services, Inc. FDA-2017-P-5845 · 4 docket documents B&H Consulting Services, Inc. filed this petition requesting that the FDA designate the drug product listed in ANDA 075597 (Mylan Pharmaceuticals Inc.) as a new Reference Standard for Ketoconazole Tablets USP, 200 mg, because the current Reference Standard product from Teva Pharmaceuticals Inc. (AND | 505(q) | 2017-09-21 | Open | B&H Consulting Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.6404
per ea
Lowest NADAC/Unit
$0.6404
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 51672402601KETOCONAZOLE 200 MG TABLET | $0.6404 | EA | Generic | — | 2026-06-17 |
| 51672402606KETOCONAZOLE 200 MG TABLET | $0.6404 | EA | 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.