TERBINAFINE HYDROCHLORIDE | A077137 | CIPLA 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.
No patent or exclusivity listings for this strength.
Cipla's terbinafine hydrochloride (NDA 077137) transitioned from discontinued status to an active prescription drug product.
Old: DISCN
New: RX
Cipla's terbinafine hydrochloride (TERBINAFINE HYDROCHLORIDE) received a therapeutic equivalence code of AB, indicating FDA approval as therapeutically equivalent to the reference product.
New: AB