TERBINAFINE HYDROCHLORIDE | A078297 | AUROBINDO PHARMA LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Unichem Pharmaceuticals (USA), Inc. FDA-2018-P-4549 · 8 docket documents Unichem Pharmaceuticals (USA), Inc. filed this petition on November 28, 2018, requesting that the FDA designate an additional reference standard for Terbinafine Tablets 250 mg in the Orange Book because the current reference listed drug, LAMISIL (Novartis), is unavailable in the market and preventin | 505(q) | 2018-11-29 | Granted | Unichem Pharmaceuticals (USA), Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1341
per ea
Lowest NADAC/Unit
$0.1341
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 65862007930TERBINAFINE HCL 250 MG TABLET | $0.1341 | EA | Generic | — | 2026-06-17 |
| 16714079501TERBINAFINE HCL 250 MG TABLET | $0.1341 | EA | Generic | — | 2026-06-17 |
| 16714079502TERBINAFINE HCL 250 MG TABLET | $0.1341 | 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.