LAMISIL

FDA-2023-P-4333

Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding LAMISIL (terbinafine hydrochloride) tablets for oral use, requesting a determination of the drug's suitability for ANDA purposes to facilitate the approval of generic versions.

FDA-2023-P-4333

Hyman, Phelps & McNamara, P.C. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Terbinafine Tablets, USP 125 mg, suitable for consideration in an ANDA. The petitioner seeks to introduce a new 125 mg tablet strength base

FDA-2021-P-1180

The law firm Hyman, Phelps & McNamara, P.C., filed this suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that the FDA declare Terbinafine Tablets, USP 125 mg, suitable for submission as an Abbrev

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