CARVEDILOL

FDA-2020-P-2166

Emprise Pharma LLC, on behalf of New Time Pharmaceutical Co, Ltd, filed a suitability petition regarding the reference package insert for Coreg, seeking FDA confirmation that the reference product's labeling is appropriate for use in developing an abbreviated new drug application or generic equivale

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, filed a petition regarding the pharmacokinetic properties and suitability of a new controlled-release formulation of carvedilol. The petitioner sought FDA guidance or determination on whether the proposed controlled-release formulatio

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