TERBINAFINE HYDROCHLORIDE | A077714 | BRECKENRIDGE PHARMACEUTICAL INC
| 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
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 51991052601TERBINAFINE 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.