COREG CR

FDA-2025-P-0101

AMTA Labs Limited submitted this citizen petition on January 9, 2025, requesting that the FDA Commissioner determine whether COREG CR (carvedilol phosphate) extended-release capsules in strengths of 10 mg, 20 mg, 40 mg, and 80 mg under NDA 022012 held by Waylis Therapeutics LLC was voluntarily withd

FDA-2020-P-2166

Emprise Pharma LLC, on behalf of New Time Pharmaceutical Co, Ltd, filed a citizen petition requesting that the FDA determine the suitability of the Coreg CR package insert as a reference standard for an ANDA submission. The petition seeks FDA guidance on whether the existing Coreg CR labeling can be

FDA-2020-P-2166

Emprise Pharma LLC, on behalf of New Time Pharmaceutical Co., Ltd., submitted this suitability petition under section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting approval to file an ANDA for Carvedilol bilayered extended-release tablets using Coreg CR capsules as the reference l

FDA-2010-P-0216

Flamel Technologies S.A., represented by Frommer Lawrence & Haug LLP, filed this citizen petition on April 19, 2010, pursuant to Sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA require all ANDAs and 505(b)(2) NDAs for generic formulations of Coreg CR (

FDA-2007-P-0058

Keller and Heckman LLP filed this suitability petition under Section 505(j)(2)(C) requesting FDA approval to file an ANDA for carvedilol phosphate in extended-release tablet form, which would differ from the reference listed drug Coreg CR (carvedilol phosphate extended-release capsules) only in dosa