TERBINAFINE HYDROCHLORIDE | A078297 | AUROBINDO PHARMA LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Unichem Pharmaceuticals (USA), Inc. FDA-2018-P-4549 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 | Denied | Unichem Pharmaceuticals (USA) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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